At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 723 enrolled
Drug / intervention
Bremelanotide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3, Randomized, Double-blind, Placebo-controlled, Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)
In Brief
A Phase 3 clinical trial evaluating Bremelanotide and Placebo for Hypoactive Sexual Desire Disorder. Completed, enrolled 723 participants across 91 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoactive Sexual Desire Disorder
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedJan 2015
Primary CompletionJul 2016
Study CompletionJun 2017
TodayJul 2026
First PostedJan 7, 2015
Enrollment StartDec 1, 2014
Primary CompletionJul 1, 2016
Study CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.5 years ago
Interventions
Bremelanotidedrug
A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Placeboother
Placebo