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)

NCTNCT04943068Other idKD-BMT-301

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 193 participants (actual)
Sponsor: Kwang Dong Pharmaceutical co., ltd. · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
South Korea
Start: 10 May 2021
Primary completion: 16 May 2023
Completion: 16 May 2023
First posted: 29 Jun 2021
Last update posted: 13 Nov 2024
Conditions: Hypoactive Sexual Desire Disorder

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2021202220232024

Ph 3
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
10 May 2021 to 16 May 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

BremelanotideDrug
PlaceboDrug

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(14)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 19 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

\[Main Inclusion Criteria\] * 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

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