Trial · NCT01382719
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
NCT01382719, Phase 2, Completed, Palatin Technologies, Inc; results first posted 2014-04-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder. Trials, record NCT01382719. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01382719
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
- NCT number
- NCT01382719
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 612 participants, actual
- Lead sponsor
- Palatin Technologies, Inc
- Conditions
- Female Sexual Arousal Disorder, Hypoactive Sexual Desire Disorder
- Interventions
- bremelanotide
- First posted
- 2011-06-27
- Last updated
- 2014-12-18
- Results first posted
- 2014-04-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE) | 4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period. | The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSEs), computed as the number of events during the last 4 weeks of treatment with FSEP-R Q10 = "Yes" minus the number of baseline events with FSEP-R Q10 = "Yes." Efficacy analyses were done with the MITT population which consisted of all randomized subjects who took at least 1 dose of double-blind treatment after the 2 in-clinic doses of double-blind medication and who had at least 1 follow-up visit (Visit 10 or later) to ensure that FSEP-R data were reviewed and confirmed by the investigative site. |
| Secondary | Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index | 4-12 weeks from baseline to end of study (total study duration 20 weeks) | The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the arousal domain were obtained from the FSFI Q3 through Q6. The score range is 0-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen \[6\], resulting in a score from 0 (min) to 6 (max). |
| Secondary | Satisfaction With Arousal as Measured by GAQ Question 1 | 4-12 weeks from baseline to end of study (total study duration 20 weeks) | This is the change in Baseline to End-of-Study in Satisfaction with Arousal as measured by GAQ Question 1. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 1 is "Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your arousal while using the study drug?" The score range is 1 (very much worse) to 7 (very much better). |
| Secondary | Desire Domain From Female Sexual Function Index | 4-12 weeks from baseline to end of study (total study duration 20 weeks) | The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the desire domain were obtained from the FSFI Q1 and Q2. The score range is 1-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen \[6\], resulting in a score from 0 (min) to 6 (max). |
| Secondary | Satisfaction With Desire as Measured by GAQ Question 2 | 4-12 weeks from baseline to end of study (total study duration 20 weeks) | This is the change in Baseline to End-of-Study in Satisfaction with Desire as Measured by GAQ Question 2. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 2 is "Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your desire while using the study drug?" The score range is 1 (very much worse) to 7 (very much better). |
| Secondary | Quality of Relationship With Partner as Measured by GAQ Question 4 | 4-12 weeks from baseline to end of study (total study duration 20 weeks) | This is the change in Baseline to End-of-Study in Quality of Relationship with Partner as Measured by GAQ Question 4. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 4 is "Compared to the start of the study (prior to taking the study drug), how has taking the study drug changed your relationship with your partner?" The score range is 1 (very much worse) to 7 (very much better). |
| Secondary | FSDS-DAO Total Score | 4 - 12 weeks from baseline to end of study (total study duration 20 weeks) | FSDS-DAO (Female Sexual Distress Scale - Desire/Arousal/Orgasm) is an assessment tool to measure female sexual distress. The change from baseline to end of study in the FSDS-DAO (total score) was measured. There are 15 questions, eg, "How often do you feel: Distressed about your sex life" and the score range was 0 (Never), 1 (Rarely), 2 (Occasionally), 3 (Frequently), 4 (Always). The score for each subject at each time point was computed as the sum of the scores from the 15 questions, resulting in a possible score at each time point between 0 and 60. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE) | 4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period. | SSEs | MEAN | |
| SECONDARY | Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index | 4-12 weeks from baseline to end of study (total study duration 20 weeks) | units on a scale | MEAN | |
| SECONDARY | Satisfaction With Arousal as Measured by GAQ Question 1 | 4-12 weeks from baseline to end of study (total study duration 20 weeks) | units on a scale | MEAN | |
| SECONDARY | Desire Domain From Female Sexual Function Index | 4-12 weeks from baseline to end of study (total study duration 20 weeks) | units on a scale | MEAN | |
| SECONDARY | Satisfaction With Desire as Measured by GAQ Question 2 | 4-12 weeks from baseline to end of study (total study duration 20 weeks) | units on a scale | MEAN | |
| SECONDARY | Quality of Relationship With Partner as Measured by GAQ Question 4 | 4-12 weeks from baseline to end of study (total study duration 20 weeks) | units on a scale | MEAN | |
| SECONDARY | FSDS-DAO Total Score | 4 - 12 weeks from baseline to end of study (total study duration 20 weeks) | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE) | Placebo | 0.2 | Standard Deviation 2.29 | SSEs | |
| The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE) | Bremelanotide Arm 1 | 0.6 | Standard Deviation 3.55 | SSEs | |
| The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE) | Bremelanotide Arm 2 | 0.7 | Standard Deviation 1.81 | SSEs | |
| The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE) | Bremelanotide Arm 3 | 0.8 | Standard Deviation 2.86 | SSEs | |
| Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index | Placebo | 0.51 | Standard Deviation 1.371 | units on a scale | |
| Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index | Bremelanotide Arm 1 | 0.35 | Standard Deviation 1.457 | units on a scale | |
| Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index | Bremelanotide Arm 2 | 0.71 | Standard Deviation 1.112 | units on a scale | |
| Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index | Bremelanotide Arm 3 | 1.06 | Standard Deviation 1.146 | units on a scale | |
| Satisfaction With Arousal as Measured by GAQ Question 1 | Placebo | 0.4 | Standard Deviation 1.37 | units on a scale | |
| Satisfaction With Arousal as Measured by GAQ Question 1 | Bremelanotide Arm 1 | 0.3 | Standard Deviation 1.43 | units on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 98 | |
| Overall Study | STARTED | Bremelanotide Arm 1 | 100 | |
| Overall Study | STARTED | Bremelanotide Arm 2 | 100 | |
| Overall Study | STARTED | Bremelanotide Arm 3 | 99 | |
| Overall Study | Subjects Not Dosed | Placebo | 1 | |
| Overall Study | Subjects Not Dosed | Bremelanotide Arm 1 | 0 | |
| Overall Study | Subjects Not Dosed | Bremelanotide Arm 2 | 1 | |
| Overall Study | Subjects Not Dosed | Bremelanotide Arm 3 | 1 | |
| Overall Study | COMPLETED | Placebo | 80 | |
| Overall Study | COMPLETED | Bremelanotide Arm 1 | 81 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events172
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 97 | 3 |
| other | Nausea | Gastrointestinal disorders | Bremelanotide Arm 1 | 18 | 100 | 34 |
| other | Nausea | Gastrointestinal disorders | Bremelanotide Arm 2 | 22 | 99 | 63 |
| other | Nausea | Gastrointestinal disorders | Bremelanotide Arm 3 | 24 | 98 | 51 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 0 | 97 | 0 |
| other | Vomiting | Gastrointestinal disorders | Bremelanotide Arm 1 | 2 | 100 | 2 |
| other | Vomiting | Gastrointestinal disorders | Bremelanotide Arm 2 | 4 | 99 | 6 |
| other | Vomiting | Gastrointestinal disorders | Bremelanotide Arm 3 | 6 | 98 | 11 |
| other | Injection site pain | General disorders | Placebo | 3 | 97 | 6 |
| other | Injection site pain | General disorders | Bremelanotide Arm 1 | 6 | 100 | 8 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Bremelanotide Arm 1 | ||
| Total, all-cause mortality | Bremelanotide Arm 2 | ||
| Total, all-cause mortality | Bremelanotide Arm 3 | ||
| Total, other adverse events | Placebo | 49 | 97 |
| Total, other adverse events | Bremelanotide Arm 1 | 64 | 100 |
| Total, other adverse events | Bremelanotide Arm 2 | 61 | 99 |
| Total, other adverse events | Bremelanotide Arm 3 | 67 | 98 |
| Total, serious adverse events | Placebo | 3 | 97 |
| Total, serious adverse events | Bremelanotide Arm 1 | 1 | 100 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01382719/results?page=2