A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension

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) a 32-week phase including a randomized, double-blind
treatment period preceded by a screening/baseline period (Core Study) and (2) a 52 week
open-label treatment phase (Extension Phase).

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.

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