DRUG
Bremelanotide
Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector.
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)
Status
Completed
Phase
Phase 3
Enrollment
193
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
Placebo
Subjects will self-administer a Placebo subcutaneously (SC) via auto-injector.
Timeline
From registration to results.
First posted
Jun 29, 2021
Study start
May 10, 2021
Primary completion
May 16, 2023
Study completion
May 16, 2023
Results posted
Not reported
Registry updated
Nov 13, 2024
Outcomes
What the study measures.
Primary outcomes
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
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)
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)
Eligibility
Who can take part.
- Minimum age
- 19 Years
- Maximum age
- Not reported
- Sex
- FEMALE
- Healthy volunteers
- No
\[Main Inclusion Criteria\] * 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
Study locations
1 registered sites.
South Korea. Showing up to 24 locations stored in the fast local snapshot.
Seoul National University Hospital
Seoul, South Korea
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
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2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
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Related PeptideStat pages
Put the record in context.
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