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)

Hypoactive Sexual Desire Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943068
• Other study ID #: KD-BMT-301
• Status: Recruiting
• Phase: Phase 3
• Start date: May 10, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Kwang Dong Pharmaceutical co., ltd.
• Contact: Soo Woong Kim, Dr
• Phone: 02-2072-2426
• Email: swkim[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

[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

Related Conditions & MeSH terms

• Hypoactive Sexual Desire Disorder
• Hypokinesia
• Sexual Dysfunctions, Psychological

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kwang Dong Pharmaceutical co., ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to End of Study in the desire domain from the FSFI		Baseline up to End of Study(8weeks)
Secondary	Change from baseline to End of Study in FSDS-DAO (Item 13)		Baseline up to End of Study(8weeks)
Secondary	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)
Secondary	Change from Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R		Baseline up to End of Study(8weeks)
Secondary	Change from Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R		Baseline up to End of Study(8weeks)
Secondary	Change from Baseline to End of Study in the FSDS-DAO Total Score		Baseline up to End of Study(8weeks)
Secondary	Change from Baseline to End of study in the total FSFI score based on the 19 questions	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.	Baseline up to End of Study(8weeks)
Secondary	Change in mean Level of Sexual Arousal from FSEP-R Q6		Baseline up to End of Study(8weeks)
Secondary	Change in mean Satisfaction with Sexual Arousal from FSEP-R Q7.		Baseline up to End of Study(8weeks)
Secondary	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)
Secondary	Change from Baseline to End of study in the arousal domain from the FSFI Q3 through Q6.		Baseline up to End of Study(8weeks)
Secondary	Change from Baseline to End of study in the total number of SSEs.		Baseline up to End of Study(8weeks)
Secondary	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)
Secondary	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)
Secondary	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)