Phase 3
N=614
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Hypoactive Sexual Desire Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02338960 ↗Enrolled (actual)
614
Serious AEs
0.7%
Results posted
Jan 2021
Primary outcome: Primary: Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. — 0.63; 0.21; 1.25; 0.70 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bremelanotide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Palatin Technologies, Inc
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. |
0.63; 0.21; 1.25; 0.70 | — |
| PRIMARY Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) |
-0.71; -0.42; -1.4; -0.9 | — |
| SECONDARY Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study (EOS) in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration |
0.0; 0.0; 0.19; -0.31 | — |
| SECONDARY Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Desire Score (Q3) From the FSEP-R |
0.04; 0.01; 0.43; 0.33 | — |
| SECONDARY Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R |
0.27; 0.11; 0.76; 0.47 | — |
| SECONDARY Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSDS-DAO Total Score |
-9.7; -5.6; -18.4; -11.1 | — |
| SECONDARY Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score |
2.45; 0.84; 5.15; 3.14 | — |
| SECONDARY Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R |
0.04; -0.01; 0.33; 0.35 | — |
| SECONDARY Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R |
0.23; 0.09; 0.60; 0.47 | — |
| SECONDARY Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO |
-0.8; -0.4; -1.3; -0.9 | — |
| SECONDARY Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6) |
0.52; 0.18; 1.19; 0.83 | — |
| SECONDARY Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Total Number of SSEs |
0.0; -0.0; 0.25; -0.35 | — |
| SECONDARY Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase |
0.78; 0.16 | — |
| SECONDARY Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Score for Feeling Bothered by Low Sexual Desire as Measured by the FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase |
-0.8; -0.4 | — |
| SECONDARY Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase |
0.1; -0.1 | — |
Summary
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02338960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.