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Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide
Stanley Althof1, Leonard R Derogatis2, Sally Greenberg3
1Case Western Reserve University School of Medicine, Department of Psychiatry, Cleveland, OH, USA.
The Journal of Sexual Medicine
|July 7, 2019
Summary
Responder analyses determined clinically meaningful improvements for bremelanotide in women with hypoactive sexual desire disorder (HSDD). Bremelanotide demonstrated significant efficacy compared to placebo, supporting its use in treating HSDD and female sexual arousal disorder (FSAD).
Area of Science:
- Clinical trials
- Pharmacology
- Sexual medicine
Background:
- Responder analyses are crucial for assessing the clinical significance of changes in subjective patient-reported outcomes (PROs) during clinical trials.
- Establishing minimal clinically important differences (MCIDs) is essential for interpreting PRO data in conditions like female sexual dysfunction (FSD).
Purpose of the Study:
- To determine the MCID for key scores on female sexual functioning questionnaires.
- To apply these MCIDs to analyze treatment response in a phase 2b study of bremelanotide for premenopausal women with hypoactive sexual desire disorder (HSDD) and/or female sexual arousal disorder (FSAD).
Main Methods:
- Utilized four types of responder analyses for 7 PRO endpoints: expert-anchored MCIDs, self-reported global benefit, receiver operating characteristic (ROC) curves, and cumulative distribution function.
- Analyzed data from a large, controlled, phase 2b, dose-finding study of bremelanotide in premenopausal women diagnosed with HSDD and/or FSAD.
- Performed prespecified and post hoc analyses on various diagnostic subgroups.
Main Results:
- Identified MCIDs for key measures including the Female Sexual Function Index (desire domain) and the Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) total score.
- Responder rates for all 7 endpoints at the 1.75 mg bremelanotide dose were statistically significant compared to placebo (P ≤ .03).
Conclusions:
- The study successfully established MCIDs and demonstrated that bremelanotide at 1.75 mg significantly improved sexual functioning in premenopausal women with HSDD/FSAD.
- These responder definitions were validated and used in subsequent phase 3 registration studies for bremelanotide.
- Multiple responder analyses provide a robust method for evaluating the clinical importance of bremelanotide's effects on HSDD and FSAD.
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