CompletedPhase 3

2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

United States714 participantsStarted 2015-01

Plain-language summary

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Main Inclusion Criteria: * Has met diagnostic criteria for HSDD for at least 6 months * Is willing and able to understand and comply with all study requirements * Has a normal pelvic examination at screening Main Exclusion Criteria: * Subjects should be generally healthy premenopausal females with no psychological, gynecological or urological conditions which might contribute to the sexual dysfunction, compromise study participation, or confound interpretation of the study results * Not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial

What they're measuring

Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.

Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)

Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Trial details

NCT IDNCT02338960

SponsorPalatin Technologies, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-08

Results submitted2019-07-19

View on ClinicalTrials.gov More Hypoactive Sexual Desire Disorder trials