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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)

NCT04943068 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2024-11-13

No results posted yet for this study

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).

Conditions

  • Hypoactive Sexual Desire Disorder

Interventions

DRUG

Bremelanotide

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Kwang Dong Pharmaceutical co., ltd.

    lead INDUSTRY

Principal Investigators

  • Soo Woong Kim, Dr · Seoul National University Hospital

  • Tak Kim, Dr · Korea University Anam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2023-05-16
Completion
2023-05-16
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04943068 on ClinicalTrials.gov