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)

Phase 3

Completed

• Conditions: Hypoactive Sexual Desire Disorder
• Interventions: Drug: Placebo; Drug: Bremelanotide

• Registration Number: NCT04943068
• Lead Sponsor: Kwang Dong Pharmaceutical co., ltd.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-10
• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-20
• Study First Posted: 2021-06-29
• Primary Completion: 2023-05-16
• Study Completion: 2023-05-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 193

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo subcutaneously (SC) via auto-injector for 4-weeks single-Blind period and for 8-weeks double-Blind period
Bremelanotide	Bremelanotide	Bremelanotide (BMT) subcutaneously (SC) via auto-injector for 8-weeks double-Blind period

Primary Outcome Measures

Name	Time	Method
Change from baseline to End of Study in the desire domain from the FSFI	Baseline up to End of Study(8weeks)

Secondary Outcome Measures

Name	Time	Method
Change in mean Satisfaction with Sexual Arousal from FSEP-R Q7.	Baseline up to End of Study(8weeks)
Change from Baseline to End of study in the scored time spent being concerned by difficulty with sexual arousal as measured by the FSDS-DAO Q14.	Baseline up to End of Study(8weeks)
Change from Baseline to End of study in the arousal domain from the FSFI Q3 through Q6.	Baseline up to End of Study(8weeks)
Change from Baseline to End of study in the total number of SSEs.	Baseline up to End of Study(8weeks)
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)
Change from Baseline to End of study in the total FSFI score based on the 19 questions	Baseline up to End of Study(8weeks)	The FSFI total score is on a scale ranging from 2 to 36. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.
Change in mean Level of Sexual Arousal from FSEP-R Q6	Baseline up to End of Study(8weeks)
Change from baseline in the desire domain from the FSFI Q1 and Q2 using all available double-blind data (visit 4, 5)	Baseline up to End of Study(8weeks)
Change from baseline in the score for feeling bothered by low sexual desire as measured by the FSDS -DAO Q13 using all available double-blind data(visit 4, 5)	Baseline up to End of Study(8weeks)
Change from baseline in the number of SSEs associated with study drug using the entire 8 weeks of the double-blind phase.	Baseline up to End of Study(8weeks)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of