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

• Status: Completed
• Trial end date: 2017-06-29
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Palatin Technologies
• Collaborators: AMAG Pharmaceuticals, Inc.; PRA Health Sciences
• Treatments: alpha-MSH

Criteria

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