Overview

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

Status:
Active, not recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
Female
Summary
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kwang Dong Pharmaceutical co., ltd.
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