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

Registered clinical trial record on ClinicalTrials.gov (NCT02338960). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results, though the sponsor has posted summary results. Status: completed. Study type: interventional. Phase: Phase 3. Sponsor: Palatin Technologies, Inc. Conditions: Hypoactive Sexual Desire Disorder. Interventions: Bremelanotide, Placebo. 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. This will be a multicenter, randomized, placebo-controlled, parallel group study in up to 80 sites in the United States of America (USA) and Canada to evaluate the efficacy and safety of a fixed dose of SC BMT versus placebo on an as-needed basis under conditions of home use in premenopausal women with HSDD (with or without decreased arousal). The study will consist of 2 phases: (1) Core Study: 4-week no-treatment qualification period, a 4-week single-blind placebo treatment period (baseline), and a 24-week double-blind treatment period where participants will self-administer placebo or BMT 1.75 mg SC via an autoinjector; and (2) Extension Phase: a 52-week open-label treatment period during which all subjects will receive BMT 1.75 mg. Primary Objective • 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. Secondary Objectives * To evaluate the efficacy of BMT in premenopausal women in the double-blind Core Study, as assessed by subject responses to questionnaires measuring sexual function, treatment satisfaction, and distress associated with sexual dysfunction. * To evaluate the safety of BMT in premenopausal women in the double-blind Core Study. * To evaluate the safety of long-term therapy with BMT in the open label Extension Phase. * To evaluate the efficacy of long-term therapy with BMT in the open-label Extension Phase. Primary outcome measures: Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.; Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13). Eligibility: 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