A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)

Kwang Dong Pharmaceutical co., ltd.193 enrolled

Overview

The purpose of this study is to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women with Hypoactive Sexual Desire Disorder(with or without Decreased Arousal).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

193

Conditions

Hypoactive Sexual Desire Disorder

Interventions

BremelanotideDRUG

Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector.

PlaceboDRUG

Subjects will self-administer a Placebo subcutaneously (SC) via auto-injector.

Eligibility

Sex: FEMALEMin age: 19 Years

Medical Language ↔ Plain English

\[Main Inclusion Criteria\] * 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

Locations (1)

Seoul National University Hospital

Seoul, South Korea