ACRONYMS AND DEFINITIONS

BP - Blood pressure

CVD - Cardiovascular disease

DVT - Deep vein thrombosis

PE - Pulmonary embolism

Testosterone buccal tablet (Striant®)

Dosage forms

Striant® buccal tablet

Each buccal tablet contains 30 mg of testosterone

Dosing

Primary and secondary hypogonadism

Dosing: 1 buccal system (30 mg) to the gum region twice a day (about 12 hours apart)
Tablet is placed just above the incisor tooth on either side of the mouth. Rotate sides of the mouth with each application.
Check morning (predose) testosterone level 4 - 12 weeks after initiating therapy
If testosterone level does not stay consistently between 300 - 1050 ng/dl, discontinue Striant
The Endocrine Society recommends checking testosterone levels immediately before or after application of fresh system [3]

Generic / Price

- NO/$$$$

Other

The rounded surface of the tablet goes against the gum and is held firmly in place with a finger over the lip and against the product for 30 seconds to ensure adhesion
If tablet dislodges during use, throw away and replace with a new tablet
Remove before oral care (brushing teeth, mouthwash, etc.)
Striant is DEA schedule III

Mechanism of action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). See testosterone physiology for more.

FDA-approved indications

Primary hypogonadism (congenital or acquired)
Secondary hypogonadism (congenital or acquired)

Side effects

NOTE: Strength of association is unknown because there was no placebo arm in trials

Gum or mouth irritation - 9.2%
Bitter taste - 4.1%
Gum pain - 3.1%
Gum tenderness - 3.1%
Headache - 3.1%
Gum edema - 2.0%
Taste perversion - 2.0%

Drug interactions

Insulin - testosterone may increase insulin sensitivity. Monitor blood sugars and adjust insulin doses if needed after starting testosterone.
Warfarin - testosterone may alter warfarin activity. More frequent INR monitoring may be required, particularly when initiating and stopping testosterone.
Corticosteroids - testosterone may potentiate the fluid retention caused by corticosteroids. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).

Lab interactions

Thyroid labs - testosterone may decrease concentrations of thyroxine-binding globulin resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free T3 and T4 levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.

Contraindications / Precautions

Long-term gum safety - there is limited data on the long-term gum safety of Striant
Breast cancer - DO NOT USE
Prostate cancer - DO NOT USE
Pregnant women or women who may become pregnant - DO NOT USE
Breastfeeding - DO NOT USE
Benign Prostatic Hyperplasia (BPH) - testosterone may worsen symptoms of BPH. DO NOT USE in severe BPH.
Congestive heart failure (CHF) - testosterone may cause fluid retention that worsens CHF. DO NOT USE in uncontrolled CHF.
Obstructive sleep apnea (OSA) - testosterone may worsen or precipitate symptoms of OSA. Use caution when prescribing to patients with OSA and those with risk factors for OSA.
Polycythemia - testosterone may increase red blood cells which can theoretically increase the risk of thrombosis. Red blood cell indices should be monitored during therapy. See monitoring therapy for more.
Prostate cancer risk - testosterone may increase the risk of prostate cancer. See monitoring therapy for more.
Cardiovascular disease - the effect of testosterone on CVD risk is unknown. Some studies have shown an increased risk while others have not. No long-term studies have been performed.
Venous thromboembolism (DVT and PE) - Cases of DVT and PE have been reported in men using testosterone. The risk may be greater with increasing hematocrit. See monitoring therapy for more.
Decreased spermatogenesis (infertility) - exogenous testosterone can suppress spermatogenesis by inhibiting FSH. Some men may experience decreased sperm counts and infertility while taking testosterone supplements.
Edema and swelling - testosterone may promote sodium and water retention leading to swelling and edema. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Liver abnormalities - oral methyltestosterone has been associated with serious hepatic adverse effects including peliosis, hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice. Long-term therapy with intramuscular testosterone enanthate has been associated with the formation of hepatic adenomas. These adverse effects have not been reported with other forms of testosterone, but a small risk may exist.
Abuse and dependence - some patients may abuse testosterone and develop physical dependence. Patients who take higher than recommended doses or concomitant synthetic androgens are at greater risk. Check testosterone levels if abuse is suspected while keeping in mind that synthetic androgens will not be detected on standard testosterone assays. Withdrawal symptoms in patients taking supratherapeutic doses include depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Symptoms may last weeks to months.
Gynecomastia - testosterone may cause gynecomastia
Lipid changes - testosterone therapy may affect lipids. Monitor for changes and treat appropriately.
Hypercalcemia - testosterone may raise calcium levels in cancer patients at risk of hypercalcemia. Monitor levels closely during therapy.
Kidney disease - has not been studied. Patients with kidney disease may be at increased risk of fluid retention from testosterone. Use caution.
Liver disease - has not been studied. Patients with liver disease may be at increased risk of fluid retention from testosterone. Use caution.

Testosterone undecanoate capsule (Jatenzo®)

Dosage forms

Capsule

158 mg
198 mg
237 mg

Dosing

Primary and secondary hypogonadism

Starting: 237 mg twice daily
Max: 396 mg twice daily
Check levels 7 days after starting therapy and dose adjustments. Levels should be drawn 6 hours after the morning dose.
Take with food

Dose adjustments based on level
Testosterone level	Current Jatenzo dose (twice daily)	New Jatenzo dose (twice daily)
< 425 ng/dl	158 mg	198 mg
	198 mg	237 mg
	237 mg	316 mg (two 158 mg capsules)
	316 mg	396 mg (two 198 mg capsules)
425 – 970 ng/dL	No dose change
> 970 ng/dl	396 mg	316 mg (two 158 mg capsules)
	316 mg	237 mg
	237 mg	198 mg
	198 mg	158 mg
	158 mg	Discontinue

Generic / Price

- NO/$$$$

Mechanism of action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). See testosterone physiology for more.

FDA-approved indications

Primary hypogonadism (congenital or acquired)
Secondary hypogonadism (congenital or acquired)

Side effects

NOTE: Strength of association is unknown because there was no placebo arm in trials

Headache - 4.8%
Hematocrit increase - 4.8%
Hypertension - 3.6%
HDL decreased - 3%
Headache - 3.1%
Nausea - 2.4%
PSA increase - in a 4-month trial, the average increase in PSA was 0.2 ng/ml. Increases from baseline of at least 1.4 ng/ml or PSA greater than 4 ng/ml, occurred in 1.9% of patients.

Drug interactions

Insulin - testosterone may increase insulin sensitivity. Monitor blood sugars and adjust insulin doses if needed after starting testosterone.
Warfarin - testosterone may alter warfarin activity. More frequent INR monitoring may be required, particularly when initiating and stopping testosterone.
Corticosteroids - testosterone may potentiate the fluid retention caused by corticosteroids. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Medications that can raise blood pressure - Jatenzo can raise blood pressure, and other blood pressure-raising medications may potentiate the effect.

Lab interactions

Thyroid labs - testosterone may decrease concentrations of thyroxine-binding globulin resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free T3 and T4 levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Contraindications / Precautions

Breast cancer - DO NOT USE
Prostate cancer - DO NOT USE
Pregnant women or women who may become pregnant - DO NOT USE
Breastfeeding - DO NOT USE
Age-related hypogonadism - DO NOT USE. Has not been studied in this condition. May raise blood pressure and increase risk of CVD disease.
Increase in blood pressure - in 4-month trials, average systolic BP increased by 4.9 mmHg and average diastolic BP increased by 2.5 mmHg. Increases in BP had not plateaued by the end of the trial. Check BP 3 weeks after starting Jatenzo and 3 weeks after dose increases. The risks and benefits of Jatenzo should be weighed carefully in patients with CVD and those with risk factors for CVD. Do not use in age-related hypogonadism.
Polycythemia - testosterone may increase red blood cells which can theoretically increase the risk of thrombosis. Red blood cell indices should be monitored during therapy. See monitoring therapy for more.
Cardiovascular disease - the effect of testosterone on CVD risk is unknown. Some studies have shown an increased risk while others have not. No long-term studies have been performed. Jatenzo can raise blood pressure which also increases the risk of CVD.
Benign Prostatic Hyperplasia (BPH) - testosterone may worsen symptoms of BPH. DO NOT USE in severe BPH.
Prostate cancer risk - testosterone may increase the risk of prostate cancer. See monitoring therapy for recommendations on checking PSA levels..
Venous thromboembolism (DVT and PE) - Cases of DVT and PE have been reported in men using testosterone. The risk may be greater with increasing hematocrit. See monitoring therapy for more.
Abuse and dependence - some patients may abuse testosterone and develop physical dependence. Patients who take higher than recommended doses or concomitant synthetic androgens are at greater risk. Check testosterone levels if abuse is suspected while keeping in mind that synthetic androgens will not be detected on standard testosterone assays. Withdrawal symptoms in patients taking supratherapeutic doses include depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Symptoms may last weeks to months.
Decreased spermatogenesis (infertility) - exogenous testosterone can suppress spermatogenesis by inhibiting FSH. Some men may experience decreased sperm counts and infertility while taking testosterone supplements.
Liver abnormalities - oral methyltestosterone has been associated with serious hepatic adverse effects including peliosis, hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice. Long-term therapy with intramuscular testosterone enanthate has been associated with the formation of hepatic adenomas. These adverse effects have not been reported with other forms of testosterone, but a small risk may exist.
Edema and swelling - testosterone may promote sodium and water retention leading to swelling and edema. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Gynecomastia - testosterone may cause gynecomastia
Obstructive sleep apnea (OSA) - testosterone may worsen or precipitate symptoms of OSA. Use caution when prescribing to patients with OSA and those with risk factors for OSA.
Lipid changes - testosterone therapy may affect lipids. Monitor for changes and treat appropriately.
Hypercalcemia - testosterone may raise calcium levels in cancer patients at risk of hypercalcemia. Monitor levels closely during therapy.
Congestive heart failure (CHF) - testosterone may cause fluid retention that worsens CHF. DO NOT USE in uncontrolled CHF.
Depression and suicidal ideation - depression and suicidal ideation have been reported in patients treated with Jatenzo. Advise patients to seek medical attention for changes in mood or behavior.
Kidney disease - has not been studied. Patients with kidney disease may be at increased risk of fluid retention from testosterone. Use caution.
Liver disease - has not been studied. Patients with liver disease may be at increased risk of fluid retention from testosterone. Use caution.

Testosterone undecanoate capsule (Tlando®)

Dosage forms

Capsule

112.5 mg

Dosing

Primary and secondary hypogonadism

Dosing: 225 mg (two 112.5 mg capsules) twice daily with food
Check serum testosterone level 3 to 4 weeks after initiation. Level should be drawn 8 to 9 hours after the morning dose. Based on results, do the following:

Testosterone 300 - 1080 ng/dL: continue Tlando
Testosterone < 300 ng/dL: discontinue Tlando
Testosterone > 1080 ng/dL: discontinue Tlando

Generic / Price

- NO/$$$$

Mechanism of action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). See testosterone physiology for more.

FDA-approved indications

Primary hypogonadism (congenital or acquired)
Secondary hypogonadism (congenital or acquired)

Side effects

NOTE: Strength of association is unknown because there was no placebo arm in trials

Blood prolactin increase - 6.3%
Hypertension - 5.1%
Hematocrit increase - 4.3%
Upper respiratory tract infection - 3.6%
Weight increase - 2.1%
Headache - 2.1%
Musculoskeletal pain - 2.1%

Drug interactions

Insulin - testosterone may increase insulin sensitivity. Monitor blood sugars and adjust insulin doses if needed after starting testosterone.
Warfarin - testosterone may alter warfarin activity. More frequent INR monitoring may be required, particularly when initiating and stopping testosterone.
Corticosteroids - testosterone may potentiate the fluid retention caused by corticosteroids. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Medications that can raise blood pressure - Tlando can raise blood pressure, and other blood pressure-raising medications may potentiate the effect.

Lab interactions

Thyroid labs - testosterone may decrease concentrations of thyroxine-binding globulin resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free T3 and T4 levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Contraindications / Precautions

Breast cancer - DO NOT USE
Prostate cancer - DO NOT USE
Pregnant women or women who may become pregnant - DO NOT USE
Breastfeeding - DO NOT USE
Age-related hypogonadism - DO NOT USE. Has not been studied in this condition. May raise blood pressure and increase risk of CVD disease.
Increase in blood pressure - in 4-month trials, average systolic BP increased by 4.3 mmHg in Tlando-treated patients. Check BP 3 weeks after starting Tlando and periodically thereafter. The risks and benefits of Tlando should be weighed carefully in patients with CVD and those with risk factors for CVD.
Polycythemia - testosterone may increase red blood cells, which can theoretically increase the risk of thrombosis. The Tlando manufacturer recommends checking a CBC every 3 months during the first year of therapy, and every 6 months thereafter. Tlando should be stopped if the hematocrit becomes abnormally high. See monitoring therapy for more recommendations.
Cardiovascular disease - the effect of testosterone on CVD risk is unknown. Some studies have shown an increased risk while others have not. No long-term studies have been performed. Tlando can raise blood pressure which also increases the risk of CVD.
Benign Prostatic Hyperplasia (BPH) - testosterone may worsen symptoms of BPH. DO NOT USE in severe BPH.
Prostate cancer risk - testosterone may increase the risk of prostate cancer. See monitoring therapy for recommendations on checking PSA levels.
Venous thromboembolism (DVT and PE) - cases of DVT and PE have been reported in men using testosterone. The risk may be greater with increasing hematocrit. See monitoring therapy for more.
Abuse and dependence - some patients may abuse testosterone and develop physical dependence. Patients who take higher than recommended doses or concomitant synthetic androgens are at greater risk. Check testosterone levels if abuse is suspected while keeping in mind that synthetic androgens will not be detected on standard testosterone assays. Withdrawal symptoms in patients taking supratherapeutic doses include depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Symptoms may last weeks to months.
Decreased spermatogenesis (infertility) - exogenous testosterone can suppress spermatogenesis by inhibiting FSH. Some men may experience decreased sperm counts and infertility while taking testosterone supplements.
Liver abnormalities - oral methyltestosterone has been associated with serious hepatic adverse effects including peliosis, hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice. Long-term therapy with intramuscular testosterone enanthate has been associated with the formation of hepatic adenomas. These adverse effects have not been reported with other forms of testosterone, but a small risk may exist.
Edema and swelling - testosterone may promote sodium and water retention leading to swelling and edema. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Gynecomastia - testosterone may cause gynecomastia
Obstructive sleep apnea (OSA) - testosterone may worsen or precipitate symptoms of OSA. Use caution when prescribing to patients with OSA and those with risk factors for OSA.
Lipid changes - testosterone therapy may affect lipids. Monitor for changes and treat appropriately.
Hypercalcemia - testosterone may raise calcium levels in cancer patients at risk of hypercalcemia. Monitor levels closely during therapy.
Increase in prolactin - Tlando may increase prolactin levels. In a 24-day trial (N=95), 6.3% of Tlando-treated patients had a mean increase in prolactin levels of 7 ng/ml. Check prolactin levels prior to therapy and 3 - 4 months after starting treatment. Discontinue Tlando if prolactin levels become elevated.
Kidney disease - has not been studied. Patients with kidney disease may be at increased risk of fluid retention from testosterone. Use caution.
Liver disease - has not been studied. Patients with liver disease may be at increased risk of fluid retention from testosterone. Use caution.

Testosterone gel | Androgel® | Fortesta® | Testim® | Vogelxo®

Dosage forms

Androgel® pump

1% gel pump - delivers 12.5 mg of testosterone per actuation. Each 88 g pump delivers 60 actuations.
1.62% gel pump - delivers 20.25 mg of testosterone per actuation. Each 88 g pump delivers 60 actuations.

Androgel® packets

1% gel packets - come in 25 mg and 50 mg doses
1.62% gel packet - comes in 20.25 mg and 40.5 mg doses

Fortesta® pump

Delivers 10 mg of testosterone per actuation
Comes in 60 g canister that delivers 120 actuations

Testim® tube

1 tube of gel contains 50 mg of testosterone

Vogelxo®

Tube - one tube of gel contains 50 mg of testosterone
Packet - one packet of gel contains 50 mg of of testosterone
Pump - 12.5 mg of testosterone per actuation. Each 88 g pump has 60 actuations.

Dosing - Androgel 1%

Primary and secondary hypogonadism

Starting: 50 mg of testosterone (4 pump actuations, two 25 mg packets, or one 50 mg packet) applied once daily in the morning
Maintenance: 25 - 100 mg a day to maintain testosterone levels between 350 - 750 ng/dl
Check morning testosterone level (predose) at 14 and 28 days after initiating therapy and after dose changes
The Endocrine Society recommends checking testosterone levels 2 - 8 hours following gel application, after the patient has been on treatment for at least 1 week [3]
Apply to the shoulders, upper arms, and/or abdomen. Evenly distribute dose between both sides of the body.

Dosing - Androgel 1.62%

Primary and secondary hypogonadism

Starting: 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet) applied once daily in the morning
Maintenance: 20.25 - 81 mg a day to maintain testosterone levels between 350 - 750 ng/dl
Check morning testosterone level (predose) at 14 and 28 days after initiating therapy and after dose changes
If level is > 750 ng/ml, decrease dose by 20.25 mg. If dose is < 350 ng/dl, increase dose by 20.25 mg.
The Endocrine Society recommends checking testosterone levels 2 - 8 hours following gel application, after the patient has been on treatment for at least 1 week [3]
Apply to clean, dry, intact skin of the upper arms and shoulders using palm of the hand. Apply to both sides of the body if using more than 20.25 mg.

Dosing - Fortesta

Primary and secondary hypogonadism

Starting: 40 mg applied once daily in the morning
Maintenance: 10 - 70 mg a day to maintain testosterone levels (drawn 2 hours after applying) between 500 - 1250 ng/dl
Check testosterone level 2 hours after applying at 14 and 35 days after initiating therapy and after dose changes
For levels > 2500 ng/dl, decrease dose by 20 mg. For levels 1250 - 2499 ng/dl, decrease dose by 10 mg. For levels 500 - 1250 ng/dl, leave dose the same. For levels < 500 ng/dl, increase dose by 10 mg.
The Endocrine Society recommends checking testosterone levels 2 - 8 hours following gel application, after the patient has been on treatment for at least 1 week [3]
Apply to clean, dry, intact skin of the front and inner thighs using one finger. Split doses > 10 mg between the thighs.

Dosing - Vogelxo / Testim

Primary and secondary hypogonadism

Starting: 50 mg of testosterone (one tube, one packet, or 4 pump actuations) applied once daily at the same time each day
Maintenance: 50 - 100 mg a day to maintain testosterone levels between 300 - 1000 ng/dl
Check morning testosterone level (predose) 14 days after initiating therapy and after dose changes
If level is < 300 ng/ml, increase dose to 100 mg once daily. Maximum recommended dose is 100 mg per day.
The Endocrine Society recommends checking testosterone levels 2 - 8 hours following gel application, after the patient has been on treatment for at least 1 week [3]
Apply to clean, dry, intact skin of the upper arms and shoulders. If using 100 mg, apply to both sides of body.

Generic / Price

Androgel 1% (1 pump) - YES/$$
Androgel 1% (30 packets) - YES/$$-$$$
Androgel 1.62% (1 pump) - YES/$$
Androgel 1.62% (30 packets) - NO/$$$$
Fortesta (1 pump) - YES/$$$
Testim/Vogelxo (1 pump) - YES/$$
Testim/Vogelxo (30 packets) - YES/$$$$
Testim/Vogelxo (30 tubes) - YES/$$$

Other

Do not apply to other parts of the body
After drying, area of application should be covered by clothing
Wash hands after applying
Avoid swimming, showering, or washing the application site for a minimum of 2 hours
Pumps should be primed before first use
Gels contain alcohol and are flammable
Testosterone gels are DEA schedule III

Studies

Variability in testosterone levels in gel-treated men, J Clin Endocrinol Metab (201) [PubMed abstract]

Mechanism of action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). See testosterone physiology for more.

FDA-approved indications

Primary hypogonadism (congenital or acquired)
Secondary hypogonadism (congenital or acquired)

Side effects

NOTE: Data from Androgel PI in a study lasting 182 days

Side effect	Androgel	Placebo
PSA increase^✝	11%	0%
Emotional lability	2.6%	0%
Hypertension	2.1%	0%
Hematocrit increase	2.1%	0%
Contact dermatitis	2.1%	0%
^✝PSA increase defined as average change from baseline > 0.75 ng/ml and/or an average PSA value > 4.0 ng/ml based on two measurements

Drug interactions

Insulin - testosterone may increase insulin sensitivity. Monitor blood sugars and adjust insulin doses if needed after starting testosterone.
Warfarin - testosterone may alter warfarin activity. More frequent INR monitoring may be required, particularly when initiating and stopping testosterone.
Corticosteroids - testosterone may potentiate the fluid retention caused by corticosteroids. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).

Lab interactions

Thyroid labs - testosterone may decrease concentrations of thyroxine-binding globulin resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free T3 and T4 levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.

Contraindications / Precautions

Secondary exposure - children and women should avoid contact with application sites. Virilization has been reported in exposed children.
Breast cancer - DO NOT USE
Prostate cancer - DO NOT USE
Pregnant women or women who may become pregnant - DO NOT USE
Breastfeeding - DO NOT USE
Benign Prostatic Hyperplasia (BPH) - testosterone may worsen symptoms of BPH. DO NOT USE in severe BPH.
Congestive heart failure (CHF) - testosterone may cause fluid retention that worsens CHF. DO NOT USE in uncontrolled CHF.
Obstructive sleep apnea (OSA) - testosterone may worsen or precipitate symptoms of OSA. Use caution when prescribing to patients with OSA and those with risk factors for OSA.
Polycythemia - testosterone may increase red blood cells which can theoretically increase the risk of thrombosis. Red blood cell indices should be monitored during therapy. See monitoring therapy for more.
Prostate cancer risk - testosterone may increase the risk of prostate cancer. See monitoring therapy for more.
Cardiovascular disease - the effect of testosterone on CVD risk is unknown. Some studies have shown an increased risk while others have not. No long-term studies have been performed.
Venous thromboembolism (DVT and PE) - Cases of DVT and PE have been reported in men using testosterone. The risk may be greater with increasing hematocrit. See monitoring therapy for more.
Decreased spermatogenesis (infertility) - exogenous testosterone can suppress spermatogenesis by inhibiting FSH. Some men may experience decreased sperm counts and infertility while taking testosterone supplements.
Edema and swelling - testosterone may promote sodium and water retention leading to swelling and edema. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Liver abnormalities - oral methyltestosterone has been associated with serious hepatic adverse effects including peliosis, hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice. Long-term therapy with intramuscular testosterone enanthate has been associated with the formation of hepatic adenomas. These adverse effects have not been reported with other forms of testosterone, but a small risk may exist.
Abuse and dependence - some patients may abuse testosterone and develop physical dependence. Patients who take higher than recommended doses or concomitant synthetic androgens are at greater risk. Check testosterone levels if abuse is suspected while keeping in mind that synthetic androgens will not be detected on standard testosterone assays. Withdrawal symptoms in patients taking supratherapeutic doses include depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Symptoms may last weeks to months.
Gynecomastia - testosterone may cause gynecomastia
Lipid changes - testosterone therapy may affect lipids. Monitor for changes and treat appropriately.
Hypercalcemia - testosterone may raise calcium levels in cancer patients at risk of hypercalcemia. Monitor levels closely during therapy.
Kidney disease - has not been studied. Patients with kidney disease may be at increased risk of fluid retention from testosterone. Use caution.
Liver disease - has not been studied. Patients with liver disease may be at increased risk of fluid retention from testosterone. Use caution.

Testosterone pellet (Testopel®)

Dosage forms

Testopel® pellet

Each pellet contains 75 mg of testosterone

Dosing

Primary and secondary hypogonadism

Dosing: 150 - 450 mg subcutaneously every 3 - 6 months
Pellet is implanted in the hip area or other fatty area
The Endocrine Society recommends checking testosterone levels at the end of the dosing interval. [2,3]
The AUA recommends that the first testosterone measurement be obtained two to four weeks after initial implant to determine if the number of inserted pellets needs to be increased or decreased to achieve the appropriate therapeutic level. Patients should then be tested after 10 - 12 weeks to determine when the next administration should occur. [4]

Generic / Price

- NO/$$$$

Other

Testosterone levels peak at 1 month, then are sustained in the normal range for 3 - 6 months [2]
Pellets are inserted in a doctor's office
Pellets are typically reinserted every 3 - 4 months
Testopel is DEA schedule III

Mechanism of action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). See testosterone physiology for more.

FDA-approved indications

Primary hypogonadism (congenital or acquired)
Secondary hypogonadism (congenital or acquired)
Delayed puberty

Side effects

NOTE: Incidence of side effects is not well-defined

Inflammation and pain at the implantation site
Anaphylactoid reactions
Pellets may extrude spontaneously
Infection at implantation site
Fibrosis at implantation site

Drug interactions

Insulin - testosterone may increase insulin sensitivity. Monitor blood sugars and adjust insulin doses if needed after starting testosterone.
Warfarin - testosterone may alter warfarin activity. More frequent INR monitoring may be required, particularly when initiating and stopping testosterone.
Corticosteroids - testosterone may potentiate the fluid retention caused by corticosteroids. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).

Lab interactions

Thyroid labs - testosterone may decrease concentrations of thyroxine-binding globulin resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free T3 and T4 levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.

Contraindications / Precautions

Breast cancer - DO NOT USE
Prostate cancer - DO NOT USE
Pregnant women or women who may become pregnant - DO NOT USE
Breastfeeding - DO NOT USE
Benign Prostatic Hyperplasia (BPH) - testosterone may worsen symptoms of BPH. DO NOT USE in severe BPH.
Congestive heart failure (CHF) - testosterone may cause fluid retention that worsens CHF. DO NOT USE in uncontrolled CHF.
Obstructive sleep apnea (OSA) - testosterone may worsen or precipitate symptoms of OSA. Use caution when prescribing to patients with OSA and those with risk factors for OSA.
Polycythemia - testosterone may increase red blood cells which can theoretically increase the risk of thrombosis. Red blood cell indices should be monitored during therapy. See monitoring therapy for more.
Prostate cancer risk - testosterone may increase the risk of prostate cancer. See monitoring therapy for more.
Cardiovascular disease - the effect of testosterone on CVD risk is unknown. Some studies have shown an increased risk while others have not. No long-term studies have been performed.
Venous thromboembolism (DVT and PE) - Cases of DVT and PE have been reported in men using testosterone. The risk may be greater with increasing hematocrit. See monitoring therapy for more.
Decreased spermatogenesis (infertility) - exogenous testosterone can suppress spermatogenesis by inhibiting FSH. Some men may experience decreased sperm counts and infertility while taking testosterone supplements.
Edema and swelling - testosterone may promote sodium and water retention leading to swelling and edema. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Liver abnormalities - oral methyltestosterone has been associated with serious hepatic adverse effects including peliosis, hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice. Long-term therapy with intramuscular testosterone enanthate has been associated with the formation of hepatic adenomas. These adverse effects have not been reported with other forms of testosterone, but a small risk may exist.
Abuse and dependence - some patients may abuse testosterone and develop physical dependence. Patients who take higher than recommended doses or concomitant synthetic androgens are at greater risk. Check testosterone levels if abuse is suspected while keeping in mind that synthetic androgens will not be detected on standard testosterone assays. Withdrawal symptoms in patients taking supratherapeutic doses include depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Symptoms may last weeks to months.
Gynecomastia - testosterone may cause gynecomastia
Lipid changes - testosterone therapy may affect lipids. Monitor for changes and treat appropriately.
Hypercalcemia - testosterone may raise calcium levels in cancer patients at risk of hypercalcemia. Monitor levels closely during therapy.
Kidney disease - has not been studied. Patients with kidney disease may be at increased risk of fluid retention from testosterone. Use caution.
Liver disease - has not been studied. Patients with liver disease may be at increased risk of fluid retention from testosterone. Use caution.

Testosterone cypionate (Depo-testosterone®)

Dosage forms

Vial

100 mg/ml (10 ml vial)
200 mg/ml (1 ml and 10 ml vial)

Dosing

Primary and secondary hypogonadism

Dosing: 50 - 400 mg IM every 2 - 4 weeks
In trials, dosing of 200 mg IM every 2 - 3 weeks was often used [1]
The Endocrine Society recommends 75 - 100 mg IM every week or 150 - 200 mg IM every 2 weeks when initiating therapy. Target testosterone level is 400 - 700 ng/dl one week after injection. If midinterval testosterone is > 600 ng/dL (24.5 nmol/L) or < 350 ng/dL (14.1 nmol/L), adjust dose or frequency. [2,3]
The AUA recommends that during initiation, testosterone levels should be checked after 3 - 4 cycles. [4]
Inject into the gluteal muscle

Generic / Price

- YES/$ (two 10 ml vials)

Other

After injection, testosterone levels rise into the supraphysiological range and then decline gradually
Store vials at room temperature
Testosterone cypionate is DEA schedule III

Mechanism of action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). See testosterone physiology for more.

FDA-approved indications

Primary hypogonadism (congenital or acquired)
Secondary hypogonadism (congenital or acquired)

Side effects

NOTE: Incidence of side effects is not well-defined

Inflammation and pain at the injection site
Fluctuations in mood and libido - secondary to peaks and valleys in testosterone levels
Cough after injection - rare. Possibly due to oil embolization.

Drug interactions

Insulin - testosterone may increase insulin sensitivity. Monitor blood sugars and adjust insulin doses if needed after starting testosterone.
Warfarin - testosterone may alter warfarin activity. More frequent INR monitoring may be required, particularly when initiating and stopping testosterone.
Corticosteroids - testosterone may potentiate the fluid retention caused by corticosteroids. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).

Lab interactions

Thyroid labs - testosterone may decrease concentrations of thyroxine-binding globulin resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free T3 and T4 levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.

Contraindications / Precautions

Breast cancer - DO NOT USE
Prostate cancer - DO NOT USE
Pregnant women or women who may become pregnant - DO NOT USE
Breastfeeding - DO NOT USE
Benign Prostatic Hyperplasia (BPH) - testosterone may worsen symptoms of BPH. DO NOT USE in severe BPH.
Congestive heart failure (CHF) - testosterone may cause fluid retention that worsens CHF. DO NOT USE in uncontrolled CHF.
Obstructive sleep apnea (OSA) - testosterone may worsen or precipitate symptoms of OSA. Use caution when prescribing to patients with OSA and those with risk factors for OSA.
Polycythemia - testosterone may increase red blood cells which can theoretically increase the risk of thrombosis. Red blood cell indices should be monitored during therapy. See monitoring therapy for more.
Prostate cancer risk - testosterone may increase the risk of prostate cancer. See monitoring therapy for more.
Cardiovascular disease - the effect of testosterone on CVD risk is unknown. Some studies have shown an increased risk while others have not. No long-term studies have been performed.
Venous thromboembolism (DVT and PE) - Cases of DVT and PE have been reported in men using testosterone. The risk may be greater with increasing hematocrit. See monitoring therapy for more.
Decreased spermatogenesis (infertility) - exogenous testosterone can suppress spermatogenesis by inhibiting FSH. Some men may experience decreased sperm counts and infertility while taking testosterone supplements.
Edema and swelling - testosterone may promote sodium and water retention leading to swelling and edema. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Liver abnormalities - oral methyltestosterone has been associated with serious hepatic adverse effects including peliosis, hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice. Long-term therapy with intramuscular testosterone enanthate has been associated with the formation of hepatic adenomas. These adverse effects have not been reported with other forms of testosterone, but a small risk may exist.
Abuse and dependence - some patients may abuse testosterone and develop physical dependence. Patients who take higher than recommended doses or concomitant synthetic androgens are at greater risk. Check testosterone levels if abuse is suspected while keeping in mind that synthetic androgens will not be detected on standard testosterone assays. Withdrawal symptoms in patients taking supratherapeutic doses include depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Symptoms may last weeks to months.
Gynecomastia - testosterone may cause gynecomastia
Lipid changes - testosterone therapy may affect lipids. Monitor for changes and treat appropriately.
Hypercalcemia - testosterone may raise calcium levels in cancer patients at risk of hypercalcemia. Monitor levels closely during therapy.
Kidney disease - has not been studied. Patients with kidney disease may be at increased risk of fluid retention from testosterone. Use caution.
Liver disease - has not been studied. Patients with liver disease may be at increased risk of fluid retention from testosterone. Use caution.

Testosterone enanthate (Delatestryl®)

Dosage forms

Vial

200 mg/ml
Comes in 5 ml vial

Dosing

Primary and secondary hypogonadism

Dosing: 50 - 400 mg IM every 2 - 4 weeks
In trials, dosing of 200 mg IM every 2 weeks was often used [1]
The Endocrine Society recommends 75 - 100 mg IM every week or 150 - 200 mg IM every 2 weeks when initiating therapy. Target testosterone level is 400 - 700 ng/dl one week after injection. If midinterval testosterone is > 600 ng/dL (24.5 nmol/L) or < 350 ng/dL (14.1 nmol/L), adjust dose or frequency. [2,3]
The AUA recommends that during initiation, testosterone levels should be checked after 3 - 4 cycles. [4]
Inject into the gluteal muscle

Delayed puberty

Dosing: 50 - 200 mg IM every 2 - 4 weeks

Palliation of inoperable mammary cancer in women

Dosing: 200 - 400 mg IM every 2 - 4 weeks

Generic / Price

- YES/$ (1 vial)

Other

After injection, testosterone levels rise into the supraphysiological range and then decline gradually
Store vials at room temperature
If stored at lower temperatures, crystals may develop. Warming and rotating vial should redissolve crystals.
Testosterone enanthate is DEA schedule III

Mechanism of action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). See testosterone physiology for more.

FDA-approved indications

Primary hypogonadism (congenital or acquired)
Secondary hypogonadism (congenital or acquired)
Delayed puberty
Palliation of inoperable mammary cancer in women

Side effects

NOTE: Incidence of side effects is not well-defined

Inflammation and pain at the injection site
Fluctuations in mood and libido - secondary to peaks and valleys in testosterone levels
Cough after injection - rare. Possibly due to oil embolization.
Anaphylactoid reactions - rare

Drug interactions

Insulin - testosterone may increase insulin sensitivity. Monitor blood sugars and adjust insulin doses if needed after starting testosterone.
Warfarin - testosterone may alter warfarin activity. More frequent INR monitoring may be required, particularly when initiating and stopping testosterone.
Corticosteroids - testosterone may potentiate the fluid retention caused by corticosteroids. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).

Lab interactions

Thyroid labs - testosterone may decrease concentrations of thyroxine-binding globulin resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free T3 and T4 levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.

Contraindications / Precautions

Breast cancer - DO NOT USE
Prostate cancer - DO NOT USE
Pregnant women or women who may become pregnant - DO NOT USE
Breastfeeding - DO NOT USE
Benign Prostatic Hyperplasia (BPH) - testosterone may worsen symptoms of BPH. DO NOT USE in severe BPH.
Congestive heart failure (CHF) - testosterone may cause fluid retention that worsens CHF. DO NOT USE in uncontrolled CHF.
Obstructive sleep apnea (OSA) - testosterone may worsen or precipitate symptoms of OSA. Use caution when prescribing to patients with OSA and those with risk factors for OSA.
Polycythemia - testosterone may increase red blood cells which can theoretically increase the risk of thrombosis. Red blood cell indices should be monitored during therapy. See monitoring therapy for more.
Prostate cancer risk - testosterone may increase the risk of prostate cancer. See monitoring therapy for more.
Cardiovascular disease - the effect of testosterone on CVD risk is unknown. Some studies have shown an increased risk while others have not. No long-term studies have been performed.
Venous thromboembolism (DVT and PE) - Cases of DVT and PE have been reported in men using testosterone. The risk may be greater with increasing hematocrit. See monitoring therapy for more.
Decreased spermatogenesis (infertility) - exogenous testosterone can suppress spermatogenesis by inhibiting FSH. Some men may experience decreased sperm counts and infertility while taking testosterone supplements.
Edema and swelling - testosterone may promote sodium and water retention leading to swelling and edema. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Liver abnormalities - long-term use of intramuscular testosterone enanthate has been associated with the formation of hepatic adenomas. Oral methyltestosterone has been associated with serious hepatic adverse effects including peliosis, hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice. These effects have not been seen with testosterone enanthate, but a small risk may exist.
Abuse and dependence - some patients may abuse testosterone and develop physical dependence. Patients who take higher than recommended doses or concomitant synthetic androgens are at greater risk. Check testosterone levels if abuse is suspected while keeping in mind that synthetic androgens will not be detected on standard testosterone assays. Withdrawal symptoms in patients taking supratherapeutic doses include depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Symptoms may last weeks to months.
Gynecomastia - testosterone may cause gynecomastia
Lipid changes - testosterone therapy may affect lipids. Monitor for changes and treat appropriately.
Hypercalcemia - testosterone may raise calcium levels in cancer patients at risk of hypercalcemia. Monitor levels closely during therapy.
Kidney disease - has not been studied. Patients with kidney disease may be at increased risk of fluid retention from testosterone. Use caution.
Liver disease - has not been studied. Patients with liver disease may be at increased risk of fluid retention from testosterone. Use caution.

Testosterone enanthate (Xyosted®)

Dosage forms

Single-dose autoinjector

50 mg/0.5 ml
75 mg/0.5 ml
100 mg/0.5 ml
Comes in carton with 4 autoinjectors

Dosing

Primary and secondary hypogonadism

Starting: 75 mg subcutaneously once weekly
Measure trough total testosterone levels 6 weeks after initiating therapy and 6 weeks after dose changes
If trough total testosterone is ≥ 650 ng/dl, decrease dose by 25 mg
If trough total testosterone is < 350 ng/dl, increase dose by 25 mg
If trough total testosterone is 350 - 649 ng/dl, leave dose the same
A trough concentration between 350 ng/dL and 650 ng/dL generally provides testosterone exposures in the normal range during the entire dosing interval
Inject subcutaneously in the abdominal region only. Avoid intramuscular or intravascular injection.

Generic / Price

- NO/$$$$ (4 autoinjectors)

Other

Store at room temperature. Do not refrigerate or freeze
Leave in carton until time of use to protect from light
Testosterone enanthate is DEA schedule III

Mechanism of action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). See testosterone physiology for more.

FDA-approved indications

Primary hypogonadism (congenital or acquired)
Secondary hypogonadism (congenital or acquired)

Side effects

NOTE: Placebo control not used in trials. Strength of association is unknown

Side effect	Xyosted for 1 year (N=150)
Hematocrit increased	14%
Hypertension	12.7%
Prostatic specific antigen (PSA) increased^✝	12%
Injection site bruising	6.7%
Headache	5.3%
Back pain	3.3%
Blood creatine phosphokinase increased	3.3%
Injection site hemorrhage	3.3%
Acne	2.7%
Blood testosterone increased	2.7%
Cough	2.7%
Edema peripheral	2.7%
Injection site erythema	2.7%
Prostatitis	2.7%
Urinary tract infection	2.7%
Abdominal pain	2.0%
Arthralgia	2.0%
Fatigue	2.0%
Hematuria	2.0%
Polycythemia	2.0%
Sleep apnea syndrome	2.0%
^✝Increases in serum PSA concentrations, defined as an increase from baseline of at least 1.4 ng/mL, or PSA greater than 4 ng/mL, led to discontinuation in 4.6% of 283 patients in 2 clinical studies

Drug interactions

Corticosteroids - testosterone may increase the fluid retention seen with corticosteroids
Insulin - testosterone may increase insulin sensitivity. Monitor blood sugars and adjust insulin doses if needed after starting testosterone.
Medications that raise blood pressure - Xyosted can raise blood pressure. When it is used concomitantly with other medications that raise blood pressure, the effect may be potentiated. Use caution.
Warfarin - testosterone may alter warfarin activity. More frequent INR monitoring may be required.

Lab interactions

Thyroid labs - testosterone may decrease concentrations of thyroxine-binding globulin resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free T3 and T4 levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.

Contraindications / Precautions

Breast cancer - DO NOT USE
Prostate cancer - DO NOT USE
Women - DO NOT USE
Breastfeeding - DO NOT USE
Increase in blood pressure - Xyosted has been shown to increase blood pressure which may increase the risk of cardiovascular events. Blood pressure should be checked before starting therapy, 6 weeks after the initiation of therapy, and as indicated thereafter. In trials, Xyosted increased systolic blood pressure by an average of 4 mmHg in the first 12 weeks of treatment, and the increase was sustained at one year of treatment. Use caution in patients with a history of hypertension and/or cardiovascular disease.
Benign Prostatic Hyperplasia (BPH) - testosterone may worsen symptoms of BPH. DO NOT USE in severe BPH.
Congestive heart failure (CHF) - testosterone may cause fluid retention that worsens CHF. DO NOT USE in uncontrolled CHF.
Obstructive sleep apnea (OSA) - testosterone may worsen or precipitate symptoms of OSA. Use caution when prescribing to patients with OSA and those with risk factors for OSA.
Polycythemia - testosterone may increase red blood cells (hematocrit). DO NOT USE in men with hematocrit > 50%.. The Xyosted PI recommends checking the hematocrit every 3 months while on therapy.
Prostate cancer risk - testosterone may increase the risk of prostate cancer. See monitoring therapy for more.
Cardiovascular disease - the effect of testosterone on CVD risk is unknown. Some studies have shown an increased risk while others have not. No long-term studies have been performed.
Venous thromboembolism (DVT and PE) - Cases of DVT and PE have been reported in men using testosterone. The risk may be greater with increasing hematocrit. See monitoring therapy for more.
Decreased spermatogenesis (infertility) - exogenous testosterone can suppress spermatogenesis by inhibiting FSH. Some men may experience decreased sperm counts and infertility while taking testosterone supplements.
Edema and swelling - testosterone may promote sodium and water retention leading to swelling and edema. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Liver abnormalities - long-term use of intramuscular testosterone enanthate has been associated with the formation of hepatic adenomas. It is unknown if Xyosted may have the same effect. Oral methyltestosterone has been associated with serious hepatic adverse effects including peliosis, hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice. These effects have not been seen with Xyosted, but a small risk may exist.
Abuse and dependence - some patients may abuse testosterone and develop physical dependence. Patients who take higher than recommended doses or concomitant synthetic androgens are at greater risk. Check testosterone levels if abuse is suspected while keeping in mind that synthetic androgens will not be detected on standard testosterone assays. Withdrawal symptoms in patients taking supratherapeutic doses include depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Symptoms may last weeks to months.
Gynecomastia - testosterone may cause gynecomastia
Lipid changes - testosterone therapy may affect lipids. Monitor for changes and treat appropriately.
Depression and suicide - cases of depression and suicide have occurred in trials where patients were treated with Xylosted. Advise patients to report concerning symptoms.
Hypercalcemia - testosterone may raise calcium levels in cancer patients at risk of hypercalcemia. Monitor levels closely during therapy.
Kidney disease - has not been studied. Patients with kidney disease may be at increased risk of fluid retention from testosterone. Use caution.
Liver disease - has not been studied. Patients with liver disease may be at increased risk of fluid retention from testosterone. Use caution.

Testosterone undecanoate (Aveed®)

Dosage forms

Vial

750 mg/3 ml (250 mg/ml)
Comes in 3 ml single use vial

Dosing

Primary and secondary hypogonadism

Dosing: 3 ml (750 mg) IM initially, followed by 3 ml (750 mg) IM in 4 weeks, then 3 ml (750 mg) IM every 10 weeks thereafter
The AUA recommends that during initiation, testosterone levels should be checked halfway between the first two 10-week injections [4]
The Endocrine Society recommends checking a testosterone level just prior to the subsequent injection [2,3]
Inject into the gluteal muscle
After injection, patients should be observed in a healthcare setting for 30 minutes to monitor for POME reaction

Generic / Price

- NO/$$$$

Other

In most men, testosterone levels stay in the normal range
In order to prescribe Aveed, healthcare professionals must complete an online training program and become enrolled in the Aveed REMS program
Store vials at room temperature
Aveed contains castor oil and benzyl benzoate
Aveed is DEA schedule III

Mechanism of action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). See testosterone physiology for more.

FDA-approved indications

Primary hypogonadism (congenital or acquired)
Secondary hypogonadism (congenital or acquired)

Side effects

NOTE: Strength of association is unknown because there was no placebo arm in trials

Acne - 5.2%
Injection site pain - 4.6%
PSA increase - 4.6% (average PSA increased from 1.0 ng/ml to 1.5 ng/ml in an 84-week trial)
Estradiol increase - 2.6%
Hypogonadism - 2.6%
Fatigue - 2%
Irritability - 2%
Hemoglobin increase - 2%
Insomnia - 2%
Mood swings - 2%

Drug interactions

Insulin - testosterone may increase insulin sensitivity. Monitor blood sugars and adjust insulin doses if needed after starting testosterone.
Warfarin - testosterone may alter warfarin activity. More frequent INR monitoring may be required, particularly when initiating and stopping testosterone.
Corticosteroids - testosterone may potentiate the fluid retention caused by corticosteroids. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).

Lab interactions

Thyroid labs - testosterone may decrease concentrations of thyroxine-binding globulin resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free T3 and T4 levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.

Contraindications / Precautions

Pulmonary Oil Microembolism (POME) - reaction causing cough, urge to cough, shortness of breath, sweating, throat tightening, chest pain, dizziness, and syncope has occurred after injection of testosterone undecanoate. Some reactions have required hospitalization. In one study, 9 POME events occurred among 3,556 patients treated with testosterone undecanoate.
Anaphylaxis after injection - has been reported. Rare.
Breast cancer - DO NOT USE
Prostate cancer - DO NOT USE
Pregnant women or women who may become pregnant - DO NOT USE
Breastfeeding - DO NOT USE
Benign Prostatic Hyperplasia (BPH) - testosterone may worsen symptoms of BPH. DO NOT USE in severe BPH.
Congestive heart failure (CHF) - testosterone may cause fluid retention that worsens CHF. DO NOT USE in uncontrolled CHF.
Obstructive sleep apnea (OSA) - testosterone may worsen or precipitate symptoms of OSA. Use caution when prescribing to patients with OSA and those with risk factors for OSA.
Polycythemia - testosterone may increase red blood cells which can theoretically increase the risk of thrombosis. Red blood cell indices should be monitored during therapy. See monitoring therapy for more.
Prostate cancer risk - testosterone may increase the risk of prostate cancer. See monitoring therapy for more.
Cardiovascular disease - the effect of testosterone on CVD risk is unknown. Some studies have shown an increased risk while others have not. No long-term studies have been performed.
Venous thromboembolism (DVT and PE) - Cases of DVT and PE have been reported in men using testosterone. The risk may be greater with increasing hematocrit. See monitoring therapy for more.
Decreased spermatogenesis (infertility) - exogenous testosterone can suppress spermatogenesis by inhibiting FSH. Some men may experience decreased sperm counts and infertility while taking testosterone supplements.
Edema and swelling - testosterone may promote sodium and water retention leading to swelling and edema. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Liver abnormalities - oral methyltestosterone has been associated with serious hepatic adverse effects including peliosis, hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice. Long-term therapy with intramuscular testosterone enanthate has been associated with the formation of hepatic adenomas. These adverse effects have not been reported with other forms of testosterone, but a small risk may exist.
Abuse and dependence - some patients may abuse testosterone and develop physical dependence. Patients who take higher than recommended doses or concomitant synthetic androgens are at greater risk. Check testosterone levels if abuse is suspected while keeping in mind that synthetic androgens will not be detected on standard testosterone assays. Withdrawal symptoms in patients taking supratherapeutic doses include depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Symptoms may last weeks to months.
Gynecomastia - testosterone may cause gynecomastia
Lipid changes - testosterone therapy may affect lipids. Monitor for changes and treat appropriately.
Hypercalcemia - testosterone may raise calcium levels in cancer patients at risk of hypercalcemia. Monitor levels closely during therapy.
Kidney disease - has not been studied. Patients with kidney disease may be at increased risk of fluid retention from testosterone. Use caution.
Liver disease - has not been studied. Manufacturer makes no recommendation.

Testosterone nasal gel (Natesto®)

Dosage forms

Natesto® gel pump

One actuation delivers 5.5 mg of testosterone nasal gel
Each pump has 60 actuations

Dosing

Primary and secondary hypogonadism

Dosing: 11 mg of testosterone (2 pump actuations; 1 actuation per nostril) intranasally 3 times daily for a total daily dose of 33 mg
Check morning testosterone level 1 month after initiating therapy
If testosterone level does not stay consistently between 300 - 1050 ng/dl, discontinue Natesto

Generic / Price

- NO/$$$$

Other

Pump should be primed with 10 actuations before very first use
Blow nose before administering dose
Gel is deposited on inside wall of nostril and then massaged in
Patients should discontinue during episodes of severe rhinitis (runny nose)
Natesto is DEA schedule III

Mechanism of action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). See testosterone physiology for more.

FDA-approved indications

Primary hypogonadism (congenital or acquired)
Secondary hypogonadism (congenital or acquired)

Side effects

NOTE: Strength of association is unknown because there was no placebo arm in trials

PSA increase - 5.1% (average increase in PSA over 90 days was 0.2 ng/ml)
Headache - 3.8%
Runny nose - 3.8%
Nosebleeds - 3.8%
Nasal discomfort - 3.8%
Nasopharyngitis - 3.8%
Bronchitis - 3.8%
Upper respiratory infection - 3.8%
Sinusitis - 3.8%
Nasal scab - 3.8%

Drug interactions

Insulin - testosterone may increase insulin sensitivity. Monitor blood sugars and adjust insulin doses if needed after starting testosterone.
Warfarin - testosterone may alter warfarin activity. More frequent INR monitoring may be required, particularly when initiating and stopping testosterone.
Corticosteroids - testosterone may increase the fluid retention seen with corticosteroids
Oxymetazoline (Afrin®) nasal spray - oxymetazoline does not affect the absorption of Natesto
Nasal sprays - the effect of nasal sprays on Natesto (besides oxymetazoline) has not been studied

Lab interactions

Thyroid labs - testosterone may decrease concentrations of thyroxine-binding globulin resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free T3 and T4 levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.

Contraindications / Precautions

Nasal abnormalities - DO NOT USE in patients with a history of nasal or sinus surgery, nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum, mucosal inflammatory disorders (e.g, Sjogren’s syndrome), or sinus disease
Long-term nasal safety - there is limited data on the long-term nasal safety of Natesto
Breast cancer - DO NOT USE
Prostate cancer - DO NOT USE
Pregnant women or women who may become pregnant - DO NOT USE
Breastfeeding - DO NOT USE
Allergic rhinitis - absorption may be decreased by up to 24%
Benign Prostatic Hyperplasia (BPH) - testosterone may worsen symptoms of BPH. DO NOT USE in severe BPH.
Congestive heart failure (CHF) - testosterone may cause fluid retention that worsens CHF. DO NOT USE in uncontrolled CHF.
Obstructive sleep apnea (OSA) - testosterone may worsen or precipitate symptoms of OSA. Use caution when prescribing to patients with OSA and those with risk factors for OSA.
Polycythemia - testosterone may increase red blood cells which can theoretically increase the risk of thrombosis. Red blood cell indices should be monitored during therapy. See monitoring therapy for more.
Prostate cancer risk - testosterone may increase the risk of prostate cancer. See monitoring therapy for more.
Cardiovascular disease - the effect of testosterone on CVD risk is unknown. Some studies have shown an increased risk while others have not. No long-term studies have been performed.
Venous thromboembolism (DVT and PE) - Cases of DVT and PE have been reported in men using testosterone. The risk may be greater with increasing hematocrit. See monitoring therapy for more.
Decreased spermatogenesis (infertility) - exogenous testosterone can suppress spermatogenesis by inhibiting FSH. Some men may experience decreased sperm counts and infertility while taking testosterone supplements.
Edema and swelling - testosterone may promote sodium and water retention leading to swelling and edema. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Liver abnormalities - oral methyltestosterone has been associated with serious hepatic adverse effects including peliosis, hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice. Long-term therapy with intramuscular testosterone enanthate has been associated with the formation of hepatic adenomas. These adverse effects have not been reported with other forms of testosterone, but a small risk may exist.
Abuse and dependence - some patients may abuse testosterone and develop physical dependence. Patients who take higher than recommended doses or concomitant synthetic androgens are at greater risk. Check testosterone levels if abuse is suspected while keeping in mind that synthetic androgens will not be detected on standard testosterone assays. Withdrawal symptoms in patients taking supratherapeutic doses include depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Symptoms may last weeks to months.
Gynecomastia - testosterone may cause gynecomastia
Lipid changes - testosterone therapy may affect lipids. Monitor for changes and treat appropriately.
Hypercalcemia - testosterone may raise calcium levels in cancer patients at risk of hypercalcemia. Monitor levels closely during therapy.
Kidney disease - has not been studied. Patients with kidney disease may be at increased risk of fluid retention from testosterone. Use caution.
Liver disease - has not been studied. Patients with liver disease may be at increased risk of fluid retention from testosterone. Use caution.

Testosterone patch (Androderm®)

Dosage forms

Patch

2 mg/24 hr
4 mg/24 hr

Dosing

Primary and secondary hypogonadism

Starting: 4 mg/24 hr patch applied nightly
Maintenance: 2 - 6 mg/24 hr applied nightly to maintain testosterone levels between 400 - 930 ng/dl
Check morning testosterone level 2 weeks after initiating therapy and after dose changes. A new patch should be applied the evening before morning level is drawn.
The Endocrine Society recommends checking testosterone levels 3 - 12 hours after patch application [3]
Apply to a clean, dry area of the skin on the back, abdomen, upper arms, or thighs

Generic / Price

- NO/$$$$

Other

Remove old patch before applying new patch
Avoid applying to bony prominences or a part of the body that may be subject to prolonged pressure during sleep or sitting (ex. the outer shoulder)
Do not apply to the scrotum
Rotate application site. Allow an interval of 7 days before applying to the same site.
Do not shower, swim, or wash patch site for a minimum of 3 hours after applying
Triamcinolone acetonide 0.1% cream (not ointment) may be applied under the central drug reservoir prior to application to reduce skin irritation
Remove before MRI scan. Patch contains aluminum
Androderm is DEA Schedule III

Mechanism of action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). See testosterone physiology for more.

FDA-approved indications

Primary hypogonadism (congenital or acquired)
Secondary hypogonadism (congenital or acquired)

Side effects

NOTE: Strength of association is unknown because there was no placebo arm in trials. Data are from men who were stable on other topical testosterone products and were switched to Androderm.

Application site itching - 17%
Application site vesicles - 6%
Back pain - 6%

Drug interactions

Insulin - testosterone may increase insulin sensitivity. Monitor blood sugars and adjust insulin doses if needed after starting testosterone.
Warfarin - testosterone may alter warfarin activity. More frequent INR monitoring may be required, particularly when initiating and stopping testosterone.
Corticosteroids - testosterone may increase the fluid retention seen with corticosteroids

Lab interactions

Thyroid labs - testosterone may decrease concentrations of thyroxine-binding globulin resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free T3 and T4 levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.

Contraindications / Precautions

Breast cancer - DO NOT USE
Prostate cancer - DO NOT USE
Pregnant women or women who may become pregnant - DO NOT USE
Breastfeeding - DO NOT USE
Benign Prostatic Hyperplasia (BPH) - testosterone may worsen symptoms of BPH. DO NOT USE in severe BPH.
Congestive heart failure (CHF) - testosterone may cause fluid retention that worsens CHF. DO NOT USE in uncontrolled CHF.
Obstructive sleep apnea (OSA) - testosterone may worsen or precipitate symptoms of OSA. Use caution when prescribing to patients with OSA and those with risk factors for OSA.
Polycythemia - testosterone may increase red blood cells which can theoretically increase the risk of thrombosis. Red blood cell indices should be monitored during therapy. See monitoring therapy for more.
MRI scans - Androderm patch contains aluminum. It should be removed before MRI scans to avoid potential burns.
Prostate cancer risk - testosterone may increase the risk of prostate cancer. See monitoring therapy for more.
Cardiovascular disease - the effect of testosterone on CVD risk is unknown. Some studies have shown an increased risk while others have not. No long-term studies have been performed.
Venous thromboembolism (DVT and PE) - Cases of DVT and PE have been reported in men using testosterone. The risk may be greater with increasing hematocrit. See monitoring therapy for more.
Decreased spermatogenesis (infertility) - exogenous testosterone can suppress spermatogenesis by inhibiting FSH. Some men may experience decreased sperm counts and infertility while taking testosterone supplements.
Edema and swelling - testosterone may promote sodium and water retention leading to swelling and edema. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Liver abnormalities - oral methyltestosterone has been associated with serious hepatic adverse effects including peliosis, hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice. Long-term therapy with intramuscular testosterone enanthate has been associated with the formation of hepatic adenomas. These adverse effects have not been reported with other forms of testosterone, but a small risk may exist.
Abuse and dependence - some patients may abuse testosterone and develop physical dependence. Patients who take higher than recommended doses or concomitant synthetic androgens are at greater risk. Check testosterone levels if abuse is suspected while keeping in mind that synthetic androgens will not be detected on standard testosterone assays. Withdrawal symptoms in patients taking supratherapeutic doses include depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Symptoms may last weeks to months.
Gynecomastia - testosterone may cause gynecomastia
Lipid changes - testosterone therapy may affect lipids. Monitor for changes and treat appropriately.
Hypercalcemia - testosterone may raise calcium levels in cancer patients at risk of hypercalcemia. Monitor levels closely during therapy.
Kidney disease - has not been studied. Patients with kidney disease may be at increased risk of fluid retention from testosterone. Use caution.
Liver disease - has not been studied. Patients with liver disease may be at increased risk of fluid retention from testosterone. Use caution.

Testosterone solution (Axiron®)

Dosage forms

Axiron® pump

Pump delivers 30 mg of testosterone in 1.5 ml of solution per actuation
Pump comes in 90 ml size that delivers 60 actuations

Dosing

Primary and secondary hypogonadism

Starting: 60 mg of testosterone (2 pump actuations) applied once daily
Maintenance: 30 - 120 mg once daily to maintain testosterone levels between 300 - 1050 ng/dl
Check testosterone level 14 days after initiating therapy and after dose changes. Level should be drawn 2 - 8 hours after applying Axiron.
If level is < 300 ng/dl, increase dose by 30 mg. If level is > 1050 ng/dl, decrease dose by 30 mg.
Axiron is applied to the axilla (armpit) using included applicator
Doses > 30 mg should be split between both axilla, allowing product to dry between application

Generic / Price

- YES/$$ (90 ml bottle)

Other

Pump should be primed with 3 actuations before very first use
Apply deodorant before Axiron
Wash hands after applying
Cover application site with clothing
Avoid swimming or washing the application site for a minimum of 2 hours after application
Axiron contains alcohol and is flammable
Axiron is DEA schedule III

Mechanism of action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). See testosterone physiology for more.

FDA-approved indications

Primary hypogonadism (congenital or acquired)
Secondary hypogonadism (congenital or acquired)

Side effects

NOTE: Strength of association is unknown because there was no placebo arm in trials

Application site irritation - 7%
Application site redness - 5%
Headache - 5%
Hematocrit increase - 4%
Diarrhea - 3%
Vomiting - 3%
PSA increase* - 1%

Drug interactions

Insulin - testosterone may increase insulin sensitivity. Monitor blood sugars and adjust insulin doses if needed after starting testosterone.
Warfarin - testosterone may alter warfarin activity. More frequent INR monitoring may be required, particularly when initiating and stopping testosterone.
Corticosteroids - testosterone may potentiate the fluid retention caused by corticosteroids. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).

Lab interactions

Thyroid labs - testosterone may decrease concentrations of thyroxine-binding globulin resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free T3 and T4 levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.

Contraindications / Precautions

Secondary exposure - children and women should avoid contact with application sites. Virilization has been reported in exposed children.
Breast cancer - DO NOT USE
Prostate cancer - DO NOT USE
Pregnant women or women who may become pregnant - DO NOT USE
Breastfeeding - DO NOT USE
Benign Prostatic Hyperplasia (BPH) - testosterone may worsen symptoms of BPH. DO NOT USE in severe BPH.
Congestive heart failure (CHF) - testosterone may cause fluid retention that worsens CHF. DO NOT USE in uncontrolled CHF.
Obstructive sleep apnea (OSA) - testosterone may worsen or precipitate symptoms of OSA. Use caution when prescribing to patients with OSA and those with risk factors for OSA.
Polycythemia - testosterone may increase red blood cells which can theoretically increase the risk of thrombosis. Red blood cell indices should be monitored during therapy. See monitoring therapy for more.
Prostate cancer risk - testosterone may increase the risk of prostate cancer. See monitoring therapy for more.
Cardiovascular disease - the effect of testosterone on CVD risk is unknown. Some studies have shown an increased risk while others have not. No long-term studies have been performed.
Venous thromboembolism (DVT and PE) - Cases of DVT and PE have been reported in men using testosterone. The risk may be greater with increasing hematocrit. See monitoring therapy for more.
Decreased spermatogenesis (infertility) - exogenous testosterone can suppress spermatogenesis by inhibiting FSH. Some men may experience decreased sperm counts and infertility while taking testosterone supplements.
Edema and swelling - testosterone may promote sodium and water retention leading to swelling and edema. Use caution in susceptible patients (e.g. heart failure, kidney disease, liver disease).
Liver abnormalities - oral methyltestosterone has been associated with serious hepatic adverse effects including peliosis, hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice. Long-term therapy with intramuscular testosterone enanthate has been associated with the formation of hepatic adenomas. These adverse effects have not been reported with other forms of testosterone, but a small risk may exist.
Abuse and dependence - some patients may abuse testosterone and develop physical dependence. Patients who take higher than recommended doses or concomitant synthetic androgens are at greater risk. Check testosterone levels if abuse is suspected while keeping in mind that synthetic androgens will not be detected on standard testosterone assays. Withdrawal symptoms in patients taking supratherapeutic doses include depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Symptoms may last weeks to months.
Gynecomastia - testosterone may cause gynecomastia
Lipid changes - testosterone therapy may affect lipids. Monitor for changes and treat appropriately.
Hypercalcemia - testosterone may raise calcium levels in cancer patients at risk of hypercalcemia. Monitor levels closely during therapy.
Kidney disease - has not been studied. Patients with kidney disease may be at increased risk of fluid retention from testosterone. Use caution.
Liver disease - has not been studied. Patients with liver disease may be at increased risk of fluid retention from testosterone. Use caution.

PRICE ($) INFO

Pricing legend

$ = 0 - $50
$$ = $51 - $100
$$$ = $101 - $150
$$$$ = > $151

Pricing based on one month of therapy at standard dosing in an adult
Pricing based on information from GoodRX.com®
Pricing may vary by region and availability

BIBLIOGRAPHY

1 - PMID 25621688 - PSA effects MA
2 - PMID 20525905 - Endocrine Soc recs
3 - PMID 29562364 - Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline, J Clin Endocrinol Metab (2018)
4 - PMID 29601923 - Evaluation and Management of Testosterone Deficiency: AUA Guideline, The Journal of Urology (2018)

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