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.
