Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual… (NCT01382719) | Clinical Trial Compass
CompletedPhase 2
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
United States612 participantsStarted 2011-06
Plain-language summary
This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of bremelanotide, administered subcutaneously on an as-needed basis under conditions of home use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD in premenopausal women.
Who can participate
Age range21 Years
SexFEMALE
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Inclusion Criteria:
Female, at least 21 years of age, and premenopausal Previously experienced sexual arousal during sexual activity and/or normal level of desire in the past for least 2 years.
Willing to engage in sexual activities Currently in stable relationship with a partner(male or female)for at least 6 months.
If subject has a male sexual partner, has recorded a score of "not impotent" or "minimally impotent" on Single-question Assessment of ED.
For at least 6 months before Screening, has met diagnostic criteria for FSAD, HSDD, or mixed FSAD/HSDD Has a negative serum pregnancy test (hCG) at Screening and, if subject's partner is male, has used a medically acceptable form of contraception for the 3 months before Screening (Visit 1), and is willing to continue for the duration of the trial and 1 month following the last dose of trial drug.
Has a normal pelvic examination. At Screening or documented within 12 months before Screening, has:normal Pap test results with or without history of positive HPV, dysplasia, or ASCUS that has resolved or been treated;Pap test results positive for ASCUS and negative for HPV;Pap test results positive for HPV AND no ASCUS or dysplasia on Pap or condyloma present upon examination.
At Screening and Visit 2, meets all necessary questionnaire scores.
Exclusion Criteria:
Medical condition that is unstable or uncontrolled despite current therapy. History of unresolved sexual trauma or abuse. Pregnant or nursing. Lifelong anorgasmia, va…
What they're measuring
1
The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE)
Timeframe: 4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period.