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 | Completed Phase 3 FDA Drug

• 1 other identifier: KD-BMT-301
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

KD-BMT-301; Bremelanotide

Outcome Measures

Primary Outcomes (1)

• Change from baseline to End of Study in the desire domain from the FSFI

  Baseline up to End of Study(8weeks)

Secondary Outcomes (14)

• Change from baseline to End of Study in FSDS-DAO (Item 13)

  Baseline up to End of Study(8weeks)

• Change from Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration

  Baseline up to End of Study(8weeks)

• Change from Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R

  Baseline up to End of Study(8weeks)

• Change from Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R

  Baseline up to End of Study(8weeks)

• Change from Baseline to End of Study in the FSDS-DAO Total Score

  Baseline up to End of Study(8weeks)

Study Arms (2)

Bremelanotide

EXPERIMENTAL

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

Drug: Bremelanotide

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Bremelanotide DRUG

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

Bremelanotide

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kwang Dong Pharmaceutical co., ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

bremelanotide

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Soo Woong Kim, Dr

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Tak Kim, Dr

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 29, 2021
• Study Start: May 10, 2021
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

KR (1)