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

Status and phase: Completed; Phase 3

Conditions: Hypoactive Sexual Desire Disorder

Treatments: Drug: Placebo; Drug: Bremelanotide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04943068

KD-BMT-301

Details and patient eligibility

About

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).

Enrollment: 193 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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193 participants in 2 patient groups, including a placebo group

Bremelanotide

Experimental group

Description:

Bremelanotide (BMT) subcutaneously (SC) via auto-injector for 8-weeks double-Blind period

Treatment:

Drug: Bremelanotide

Placebo

Placebo Comparator group

Description:

Placebo subcutaneously (SC) via auto-injector for 4-weeks single-Blind period and for 8-weeks double-Blind period

Treatment:

Drug: Placebo