BREMELANOTIDE (VYLEESI®)















RECONNECT studies - Bremelanotide vs Placebo for HSDD in Premenopausal Women, Obstet Gynecol (2019) [PubMed abstract]
  • The RECONNECT studies enrolled a total of 1247 premenopausal women with HSDD. Both studies were identical and combined results are presented below.
Main inclusion criteria
  • Healthy females ≥ 18 years old
  • Acquired or generalized HSDD for ≥ 6 months
  • Prior normal sexual function for ≥ 2 years
  • Willing to engage in sexual activities ≥ 1 time per month
  • Stable monogamous relationships with a male or female partner
Main exclusion criteria
  • Pregnant or nursing
  • Treated for depression, psychosis, bipolar disorder, or substance abuse within 6 months
  • Taking neuroleptics, lithium, antidepressants, mood stabilizers, benzodiazepines, cognitive enhancers within 3 months
Baseline characteristics
  • Average age 39 years
  • Average BMI - 29
  • White - 86%
  • Average FSFI-D score - 2.0
  • Average FSDS-DAO score - 2.9
  • Partner gender: Male - 98% | Female - 2%
Randomized treatment groups
  • Group 1 (596 patients): Bremelanotide 1.75 mg subcutaneously approximately 45 minutes before sexual activity
  • Group 2 (606 patients): Placebo
  • The study had a single-blind run-in period of one month where placebo injection was given and baseline measures were established
  • Patients could administer a maximum of 12 doses in each 4-week period with no more than one dose per 24-hour period
Primary outcome: Change from baseline to end-of-study (defined as the patients’ last visit) in the FSFI-D score, comprised of questions 1 and 2, and change from baseline to end-of-study in the score for feeling bothered by low sexual desire as measured by the FSDS-DAO item 13.
  • FSFI-D questions: Over the past 4 weeks, how often did you feel sexual desire or interest? Over the past 4 weeks, how would you rate your level (degree) of sexual desire or interest? (scale 1 - 5 with 5=always, 1=never)
  • FSDS-DAO question: How often did you feel bothered by low sexual desire? (scale 0 - 4 with 4=always, 0=never)
Results

Duration: 24 weeks
Outcome Bremelanotide Placebo Comparisons
FSFI-D score increase Bremelanotide minus placebo: 0.35 p<0.001
FSFI-DAO score decrease Bremelanotide minus placebo: 0.33 p<0.001
Nausea 40% 1.3% N/A
Flushing 20.3% 0.3% N/A
Headache 11.3% 1.9% N/A
Injection site reaction 5.4% 0.5% N/A
Vomiting 4.8% 0.2% N/A
  • Bremelanotide raised blood pressure by an average of 3/2 mmHg when compared to placebo. Increases occurred within 2 hours of dosing and returned to baseline in 8 - 10 hours.

Findings: Both studies demonstrated that bremelanotide significantly improved sexual desire and related distress in premenopausal women with hypoactive sexual desire disorder. The safety profile was favorable. Most treatment-emergent adverse events were related to tolerability and the majority were mild or moderate in intensity.



  • Reference [1]
Side effect Bremelanotide
(N=627)		 Placebo
(N=620)
Nausea 40.0% 1.3%
Flushing 20.3% 0.3%
Injection site reactions 13.2% 8.4%
Headache 11.3% 1.9%
Vomiting 4.8% 0.2%
Cough 3.3% 1.3%
Fatigue 3.2% 0.5%
Hot flush 2.7% 0.2%
Paraesthesia 2.6% 0.0%
Dizziness 2.2% 0.5%
Nasal congestion 2.1% 0.5%