Trial · NCT02333071
1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
NCT02333071, Phase 3, Completed, Palatin Technologies, Inc; results first posted 2020-12-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder. Trials, record NCT02333071. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02333071
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
- NCT number
- NCT02333071
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 723 participants, actual
- Lead sponsor
- Palatin Technologies, Inc
- Conditions
- Hypoactive Sexual Desire Disorder
- Interventions
- Bremelanotide, Placebo
- First posted
- 2015-01-07
- Last updated
- 2021-04-09
- Results first posted
- 2020-12-23
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | As measured by change from baseline to end-of-study in the desire domain from the FSFI (Question Q1 and Q2), 28-day recall, co-primary endpoint - FSFI desire domain. FSFI = Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. Its six subscales assess desire, arousal, lubrication, orgasm, satisfaction, and pain, by summing individual items that comprise the subscale and multiplying the sum by a factor, resulting in a score ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome. |
| Primary | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | As measured by the change from baseline to End-of-Study of the Core Study in the bothered by low desire item from the FSDS-DAO (Female Sexual Distress Scale - Desire Arousal Orgasm) (item 13).: co-primary endpoint - FSDS-DAO bothered by low desire item 13. Responses range from 0 (never) to 4 (always). Decreasing scores on this scale represent an increase in sexual desire (positive outcome). |
| Secondary | Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | Patient's change, from baseline to end of study (EOS), in the number of Satisfying Sexual Events (SSEs), as measured by a response of 'Yes' to question 10 (Q10) of the Female Sexual Encounter Profile-Revised questionnaire (FSEP-R). The end point was calculated as the number of events during the last 4 weeks of treatment with Q10 = Yes minus the number of baseline events with Q10 = Yes. |
| Secondary | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | Scores range from 0 (no desire) to 3 (high desire) for an individual encounter. Change from baseline is computed as the mean of the scores from all encounters for a subject in the last 28 days minus the mean of the scores from all encounters for the subject in the last 28 days before Visit 3. Only FSEP-R data pertaining to encounters recorded within 72 hours of the encounter are included. |
| Secondary | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | Patient's change, from baseline to end of study (EOS), in mean satisfaction with desire score, as measured by a response to question 4 (Q4) of the Female Sexual Encounter Profile-Revised questionnaire (FSEP-R). Responses range from 1 (Not at all satisfied) to 4 (Completely satisfied). |
| Secondary | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm Scores range from 0 (never feel bothered) to 60 (always feel bothered). |
| Secondary | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function. 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. |
| Secondary | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (not at all aroused) to 3 (highly aroused) for an individual encounter. A higher score indicates a better outcome. |
| Secondary | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (not at all aroused) to 3 (highly aroused) for an individual encounter. A higher score indicates a better outcome. |
| Secondary | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | FSDS-DAO = Female Sexual Distress Scale-Desire/Arousal/Orgasm. The outcome reported is the mean score from the 15-item self assessment. The result is on a scale ranging from 0 ("never") to 4 ("always"). A higher score indicates a worse outcome. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total of 363 of the 464 subjects who completed the Core Study Phase continued into the optional OLE Study Phase, including 124 in the BMT/BMT group and 239 in the PBO/BMT group. | score on a scale | MEAN |
| PRIMARY | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. | score on a scale | MEAN |
| SECONDARY | Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks. | events | MEAN |
| SECONDARY | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks. | score on a scale | MEAN |
| SECONDARY | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks. | score on a scale | MEAN |
| SECONDARY | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks. | score on a scale | MEAN |
| SECONDARY | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks. | score on a scale | MEAN |
| SECONDARY | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks. | score on a scale | MEAN |
| SECONDARY | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks. | score on a scale | MEAN |
| SECONDARY | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks. | score on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. | Bremelanotide BMT/BMT | Main study | 0.54 | Standard Deviation 1.106 | score on a scale |
| Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. | Placebo PBO/BMT | Main study | 0.24 | Standard Deviation 0.994 | score on a scale |
| Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. | Bremelanotide BMT/BMT | Open label extension | 1.30 | Standard Deviation 1.105 | score on a scale |
| Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. | Placebo PBO/BMT | Open label extension | 0.77 | Standard Deviation 1.138 | score on a scale |
| Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | Bremelanotide BMT/BMT | Main study | -0.73 | Standard Deviation 1.203 | score on a scale |
| Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | Placebo PBO/BMT | Main study | -0.36 | Standard Deviation 1.082 | score on a scale |
| Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | Bremelanotide BMT/BMT | Open label extension | -1.7 | Standard Deviation 1.21 | score on a scale |
| Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | Placebo PBO/BMT | Open label extension | -0.9 | Standard Deviation 1.10 | score on a scale |
| Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration | Bremelanotide BMT/BMT | Main study | 0.0 | Standard Deviation 1.44 | events |
| Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration | Placebo PBO/BMT | Main study | -0.1 | Standard Deviation 1.35 | events |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Study | STARTED | Placebo PBO/BMT | 326 | |
| Core Study | STARTED | Bremelanotide BMT/BMT | 327 | |
| Core Study | Received Intervention | Placebo PBO/BMT | 319 | |
| Core Study | Received Intervention | Bremelanotide BMT/BMT | 324 | |
| Core Study | COMPLETED | Placebo PBO/BMT | 274 | |
| Core Study | COMPLETED | Bremelanotide BMT/BMT | 190 | |
| Core Study | NOT COMPLETED | Placebo PBO/BMT | 52 | |
| Core Study | NOT COMPLETED | Bremelanotide BMT/BMT | 137 | |
| Open Label Extension | STARTED | Placebo PBO/BMT | 239 | |
| Open Label Extension | STARTED | Bremelanotide BMT/BMT | 124 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events136
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 | Flushing | Vascular disorders | Bremelanotide (Main Study) | 84 | 324 | |
| other | Flushing | Vascular disorders | Placebo (Main Study) | 2 | 319 | |
| other | Flushing | Vascular disorders | Bremelanotide (OLE) | 24 | 124 | |
| other | Flushing | Vascular disorders | Placebo (OLE) | 65 | 239 | |
| other | Headache | Nervous system disorders | Bremelanotide (Main Study) | 32 | 324 | |
| other | Headache | Nervous system disorders | Placebo (Main Study) | 8 | 319 | |
| other | Headache | Nervous system disorders | Bremelanotide (OLE) | 13 | 124 | |
| other | Headache | Nervous system disorders | Placebo (OLE) | 31 | 239 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Bremelanotide (Main Study) | 8 | 324 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo (Main Study) | 4 | 319 |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bremelanotide (Main Study) | 0 | 324 |
| Total, all-cause mortality | Placebo (Main Study) | 0 | 319 |
| Total, all-cause mortality | Bremelanotide (OLE) | 0 | 124 |
| Total, all-cause mortality | Placebo (OLE) | 0 | 239 |
| Total, other adverse events | Bremelanotide (Main Study) | 255 | 324 |
| Total, other adverse events | Placebo (Main Study) | 160 | 319 |
| Total, other adverse events | Bremelanotide (OLE) | 95 | 124 |
| Total, other adverse events | Placebo (OLE) | 200 | 239 |
| Total, serious adverse events | Bremelanotide (Main Study) | 4 | 324 |
| Total, serious adverse events | Placebo (Main Study) | 1 | 319 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
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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