Trial · NCT02338960
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
NCT02338960, Phase 3, Completed, Palatin Technologies, Inc; results first posted 2021-01-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder. Trials, record NCT02338960. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02338960
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
- NCT number
- NCT02338960
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 714 participants, actual
- Lead sponsor
- Palatin Technologies, Inc
- Conditions
- Hypoactive Sexual Desire Disorder
- Interventions
- Bremelanotide, Placebo
- First posted
- 2015-01-15
- Last updated
- 2021-01-28
- Results first posted
- 2021-01-28
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 This score is on a scale ranging from 1.2 to 6. A higher score on this scale represent an increase in sexual desire and is a better 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 (item 13). Responses range from 0 (never) to 4 (always). Lower scores on this scale represent an increase in sexual desire and indicate a better outcome. Higher scores indicate a worse outcome. |
| 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 | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | Mean change from Baseline to end of study (EOS) in the number of satisfying sexual events (SSEs) that occurred within 16 hours of study drug dosing and reported within 72 hours. An increase in number indicates a better outcome. |
| 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 | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where an increase in value indicates a better outcome. |
| 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 | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome. |
| 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 | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. All responses are on a scale ranging from 0 ("never") to 4 ("always"). Total Scores range from 0 (never feel bothered) to 60 (always feel bothered). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome. The score is the mean change from Baseline observed at EOS (Baseline score - EOS score) |
| Secondary | Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | Female Sexual Function Index (FSFI) The score is computed programmatically \] resulting in a score on a scale ranging from 1.2 to 6 (Note: OLE: Open-label extension. Scores range from 2 to 36. An improvement in total FSFI score is an increase from baseline. A higher score on this scale represents an increase in sexual desire and is a better outcome. |
| 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 | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome. |
| 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 | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome. |
| 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 | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. Scores on this scale range from 0 ("never") to 4 ("always"). Decreased scores indicate improvement. A higher score on this scale 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 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. | 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 321 of the 392 (81.9%) 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 (EOS) 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 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 participants in the OLE study completed the 52 weeks. | events | MEAN |
| 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 | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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 the Change in 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 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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 the Change in Baseline to End of Study in the FSDS-DAO Total Score | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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 the Change in Baseline to End of Study in the FSFI Total Score | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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 the Change in 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 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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 the Change in 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 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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 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 | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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 | 0.63 | Standard Deviation 1.036 | 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 | 0.21 | Standard Deviation 0.922 | 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 | 1.25 | Standard Deviation 1.158 | 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 | 0.70 | Standard Deviation 1.220 | score on a scale |
| Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | Bremelanotide BMT/BMT | Main study | -0.71 | Standard Deviation 1.145 | score on a scale |
| Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | Placebo PBO/BMT | Main study | -0.42 | Standard Deviation 1.047 | score on a scale |
| Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | Bremelanotide BMT/BMT | Open label extension | -1.4 | Standard Deviation 1.20 | 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 1.07 | score on a scale |
| 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 | Bremelanotide BMT/BMT | Main study | 0.0 | Standard Deviation 1.34 | events |
| 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 | Placebo PBO/BMT | Main study | 0.0 | Standard Deviation 1.20 | 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 | 306 | |
| Core Study | STARTED | Brememlanotide BMT/BMT | 308 | |
| Core Study | Received Intervention | Placebo PBO/BMT | 303 | |
| Core Study | Received Intervention | Brememlanotide BMT/BMT | 301 | |
| Core Study | COMPLETED | Placebo PBO/BMT | 219 | |
| Core Study | COMPLETED | Brememlanotide BMT/BMT | 173 | |
| Core Study | NOT COMPLETED | Placebo PBO/BMT | 87 | |
| Core Study | NOT COMPLETED | Brememlanotide BMT/BMT | 135 | |
| Open Label Extension | STARTED | Placebo PBO/BMT | 191 | |
| Open Label Extension | STARTED | Brememlanotide BMT/BMT | 130 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events156
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 | Bremelanotide (Main Study) | 111 | 303 | |
| other | Nausea | Gastrointestinal disorders | Placebo (Main Study) | 0 | 301 | |
| other | Nausea | Gastrointestinal disorders | Bremelanotide (OLE) | 37 | 130 | |
| other | Nausea | Gastrointestinal disorders | Placebo (OLE) | 84 | 191 | |
| other | Vomiting | Gastrointestinal disorders | Bremelanotide (Main Study) | 13 | 303 | |
| other | Vomiting | Gastrointestinal disorders | Placebo (Main Study) | 1 | 301 | |
| other | Vomiting | Gastrointestinal disorders | Bremelanotide (OLE) | 3 | 130 | |
| other | Vomiting | Gastrointestinal disorders | Placebo (OLE) | 9 | 191 | |
| other | Sinusitis | Infections and infestations | Bremelanotide (Main Study) | 14 | 303 | |
| other | Sinusitis | Infections and infestations | Placebo (Main Study) | 13 | 301 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 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 | 303 |
| Total, all-cause mortality | Placebo (Main Study) | 0 | 301 |
| Total, all-cause mortality | Bremelanotide (OLE) | 0 | 130 |
| Total, all-cause mortality | Placebo (OLE) | 0 | 191 |
| Total, other adverse events | Bremelanotide (Main Study) | 224 | 303 |
| Total, other adverse events | Placebo (Main Study) | 137 | 301 |
| Total, other adverse events | Bremelanotide (OLE) | 93 | 130 |
| Total, other adverse events | Placebo (OLE) | 142 | 191 |
| Total, serious adverse events | Bremelanotide (Main Study) | 3 | 303 |
| Total, serious adverse events | Placebo (Main Study) | 2 | 301 |
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.
GET https://conductscience.org/api/trials/v1/NCT02338960
GET https://conductscience.org/api/trials/v1/NCT02338960/results?page=2