Hypoactive Sexual Desire Disorder
Conditions
Keywords
HSDD, Female Sexual Desire Disorder
Brief 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.
Detailed description
This will be a multicenter, randomized, placebo-controlled, parallel group study in up to 80 sites in the United States of America (USA) and Canada to evaluate the efficacy and safety of a fixed dose of SC BMT versus placebo on an as-needed basis under conditions of home use in premenopausal women with HSDD (with or without decreased arousal). The study will consist of 2 phases: (1) Core Study: 4-week no-treatment qualification period, a 4-week single-blind placebo treatment period (baseline), and a 24-week double-blind treatment period where participants will self-administer placebo or BMT 1.75 mg SC via an autoinjector; and (2) Extension Phase: a 52-week open-label treatment period during which all subjects will receive BMT 1.75 mg. Primary Objective • 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. Secondary Objectives * To evaluate the efficacy of BMT in premenopausal women in the double-blind Core Study, as assessed by subject responses to questionnaires measuring sexual function, treatment satisfaction, and distress associated with sexual dysfunction. * To evaluate the safety of BMT in premenopausal women in the double-blind Core Study. * To evaluate the safety of long-term therapy with BMT in the open label Extension Phase. * To evaluate the efficacy of long-term therapy with BMT in the open-label Extension Phase.
Interventions
DRUGBremelanotide
A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
OTHERPlacebo
Placebo
Sponsors
Palatin Technologies, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6) | 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 score is on a scale ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a better outcome. |
| Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total Number of SSEs | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | Change from Baseline to EOS in the total number of satisfying sexual events SSEs that occurred within 16 hours of a study drug dosing and reported within 72 hours. A higher value indicates a better outcome. |
| Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase | 24 weeks (Main Study) | FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function. The score is on a scale ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome. |
| Change From Baseline to End of Study in the Total Score for FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase | 24 weeks (Main Study) | FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. The score is on a scale ranging from 0 (never) to 4 (always). A higher score indicates a worse outcome. The score is the mean change from Baseline observed at EOS (Baseline score - EOS score) for FSDS-DAO Item 13 (feeling bothered by low sexual desire). |
| Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Number of SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase | 24 weeks (Main Study) | Mean change from Baseline to 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 reflects a positive outcome. |
| 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. |
| 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. |
Countries
Canada, United States
Participant flow
Recruitment details
Core (Main) Study consisted of a 4-week no drug Screening period, followed by a 4-week single blind PBO period, first dose administered in-clinic. Following the end of single-blind period, which served as Baseline, eligible subjects were then randomized to a 24-week double-blind outpatient treatment period, first dose administered in-clinic.
Pre-assignment details
Core Study: 723 participants enrolled, 70 run-in failures 653 participants were randomized. OLE Study (optional): Of the 464 completers of the Core study, 363 participants enrolled in optional OLE study. The OLE study was not reported and has no NCT number.
Participants by arm
| Arm | Count |
|---|---|
| Bremelanotide (BMT/BMT) Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours (Main) followed by a 52-week open label extension study (OLE)
BMT/BMT
bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | 324 |
| Placebo (PBO/BMT) Subjects will self-administer a fixed dose of placebo (PBO) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours (Main) followed by a 52-week open label extension study (OLE) where participants receive only BMT, no placebo
PBO/BMT
Placebo: Placebo bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | 319 |
| Total | 643 |
Baseline characteristics
| Characteristic | Bremelanotide (BMT/BMT) | Placebo (PBO/BMT) | Total |
|---|---|---|---|
| Age, Continuous Main | 38.4 Years STANDARD_DEVIATION 6.95 | 38.5 Years STANDARD_DEVIATION 7.22 | 38.5 Years STANDARD_DEVIATION 7.08 |
| Age, Continuous OLE | 38.5 Years STANDARD_DEVIATION 6.72 | 38.8 Years STANDARD_DEVIATION 6.93 | 38.7 Years STANDARD_DEVIATION 6.85 |
| Ethnicity (NIH/OMB) Main Hispanic or Latino | 33 Participants | 31 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Main Not Hispanic or Latino | 291 Participants | 288 Participants | 579 Participants |
| Ethnicity (NIH/OMB) Main Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) OLE Hispanic or Latino | 13 Participants | 20 Participants | 33 Participants |
| Ethnicity (NIH/OMB) OLE Not Hispanic or Latino | 111 Participants | 219 Participants | 330 Participants |
| Ethnicity (NIH/OMB) OLE Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Main American Indian or Alaska Native | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Main Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Main Black or African American | 44 Participants | 42 Participants | 86 Participants |
| Race (NIH/OMB) Main More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Main Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Main Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Main White | 273 Participants | 269 Participants | 542 Participants |
| Race (NIH/OMB) OLE American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) OLE Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) OLE Black or African American | 17 Participants | 29 Participants | 46 Participants |
| Race (NIH/OMB) OLE More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) OLE Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) OLE Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) OLE White | 101 Participants | 204 Participants | 305 Participants |
| Sex: Female, Male Main Female | 324 Participants | 319 Participants | 643 Participants |
| Sex: Female, Male Main Male | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male OLE Female | 124 Participants | 239 Participants | 363 Participants |
| Sex: Female, Male OLE Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 324 | 0 / 319 | 0 / 124 | 0 / 239 |
| other Total, other adverse events | 255 / 324 | 160 / 319 | 95 / 124 | 200 / 239 |
| serious Total, serious adverse events | 4 / 324 | 1 / 319 | 0 / 124 | 2 / 239 |
Outcome results
Primary
Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)
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).
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | Main study | -0.73 score on a scale | Standard Deviation 1.203 |
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | Open label extension | -1.7 score on a scale | Standard Deviation 1.21 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | Main study | -0.36 score on a scale | Standard Deviation 1.082 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | Open label extension | -0.9 score on a scale | Standard Deviation 1.1 |
Primary
Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. | Main study | 0.54 score on a scale | Standard Deviation 1.106 |
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. | Open label extension | 1.30 score on a scale | Standard Deviation 1.105 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. | Main study | 0.24 score on a scale | Standard Deviation 0.994 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. | Open label extension | 0.77 score on a scale | Standard Deviation 1.138 |
Secondary
Change From Baseline to End of Study in the Total Score for FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase
FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. The score is on a scale ranging from 0 (never) to 4 (always). A higher score indicates a worse outcome. The score is the mean change from Baseline observed at EOS (Baseline score - EOS score) for FSDS-DAO Item 13 (feeling bothered by low sexual desire).
Time frame: 24 weeks (Main Study)
Population: Number of participants in just the double-blind study. The OLE study was not a double-blind study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bremelanotide BMT/BMT | Change From Baseline to End of Study in the Total Score for FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase | -0.9 score on a scale | Standard Deviation 1.23 |
| Placebo PBO/BMT | Change From Baseline to End of Study in the Total Score for FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase | -0.3 score on a scale | Standard Deviation 1.05 |
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
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bremelanotide BMT/BMT | 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 | Open label extension | 0.66 score on a scale | Standard Deviation 0.975 |
| Bremelanotide BMT/BMT | 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 | Main study | 0.0 score on a scale | Standard Deviation 1.09 |
| Placebo PBO/BMT | 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 | Main study | 0.1 score on a scale | Standard Deviation 0.92 |
| Placebo PBO/BMT | 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 | Open label extension | 0.38 score on a scale | Standard Deviation 1.107 |
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
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).
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bremelanotide BMT/BMT | 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 | Main study | 0.2 score on a scale | Standard Deviation 1.15 |
| Bremelanotide BMT/BMT | 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 | Open label extension | 0.93 score on a scale | Standard Deviation 1.141 |
| Placebo PBO/BMT | 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 | Main study | 0.0 score on a scale | Standard Deviation 0.96 |
| Placebo PBO/BMT | 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 | Open label extension | 0.59 score on a scale | Standard Deviation 1.054 |
Secondary
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6)
FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function. The score is on a scale ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a better outcome.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6) | Main study | 0.66 score on a scale | Standard Deviation 1.596 |
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6) | Open label extension | 1.46 score on a scale | Standard Deviation 1.724 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6) | Main study | 0.16 score on a scale | Standard Deviation 1.24 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6) | Open label extension | 1.08 score on a scale | Standard Deviation 1.581 |
Secondary
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase
FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function. The score is on a scale ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.
Time frame: 24 weeks (Main Study)
Population: Number of participants in just the double-blind study. The OLE study was not a double-blind study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase | 0.69 score on a scale | Standard Deviation 1.114 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase | 0.23 score on a scale | Standard Deviation 0.933 |
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
FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm Scores range from 0 (never feel bothered) to 60 (always feel bothered).
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score | Main study | -9.2 score on a scale | Standard Deviation 13.86 |
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score | Open label extension | -21.4 score on a scale | Standard Deviation 13.96 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score | Main study | -5.5 score on a scale | Standard Deviation 12.27 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score | Open label extension | -12.0 score on a scale | Standard Deviation 13.66 |
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
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bremelanotide BMT/BMT | 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 | Main study | 0.1 score on a scale | Standard Deviation 1.11 |
| Bremelanotide BMT/BMT | 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 | Open label extension | 0.65 score on a scale | Standard Deviation 1.035 |
| Placebo PBO/BMT | 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 | Main study | -0.1 score on a scale | Standard Deviation 0.93 |
| Placebo PBO/BMT | 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 | Open label extension | 0.43 score on a scale | Standard Deviation 1.029 |
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
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bremelanotide BMT/BMT | 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 | Main study | 0.2 score on a scale | Standard Deviation 1.2 |
| Bremelanotide BMT/BMT | 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 | Open label extension | 0.99 score on a scale | Standard Deviation 1.17 |
| Placebo PBO/BMT | 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 | Main study | -0.1 score on a scale | Standard Deviation 1.02 |
| Placebo PBO/BMT | 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 | Open label extension | 0.60 score on a scale | Standard Deviation 1.116 |
Secondary
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Number of SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase
Mean change from Baseline to 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 reflects a positive outcome.
Time frame: 24 weeks (Main Study)
Population: Number of participants in just the double-blind study. The OLE study was not a double-blind study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From 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 events | Standard Deviation 1.66 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From 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 events | Standard Deviation 1.37 |
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
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bremelanotide BMT/BMT | 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 | Main study | -0.6 score on a scale | Standard Deviation 1.24 |
| Bremelanotide BMT/BMT | 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 | Open label extension | -1.5 score on a scale | Standard Deviation 1.23 |
| Placebo PBO/BMT | 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 | Main study | -0.4 score on a scale | Standard Deviation 1.07 |
| Placebo PBO/BMT | 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 | Open label extension | -1.0 score on a scale | Standard Deviation 1.12 |
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
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score | Main study | 2.69 score on a scale | Standard Deviation 7.317 |
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score | Open label extension | 7.71 score on a scale | Standard Deviation 8.076 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score | Main study | 0.95 score on a scale | Standard Deviation 5.963 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score | Open label extension | 3.95 score on a scale | Standard Deviation 6.74 |
Secondary
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total Number of SSEs
Change from Baseline to EOS in the total number of satisfying sexual events SSEs that occurred within 16 hours of a study drug dosing and reported within 72 hours. A higher value indicates a better outcome.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total Number of SSEs | Main study | -0.1 events | Standard Deviation 1.76 |
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total Number of SSEs | Open label extension | 0.65 events | Standard Deviation 1.676 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total Number of SSEs | Main study | -0.2 events | Standard Deviation 1.79 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total Number of SSEs | Open label extension | 0.05 events | Standard Deviation 1.553 |
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
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bremelanotide BMT/BMT | 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 | Main study | 0.0 events | Standard Deviation 1.44 |
| Bremelanotide BMT/BMT | 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 | Open label extension | 0.28 events | Standard Deviation 1.457 |
| Placebo PBO/BMT | 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 | Main study | -0.1 events | Standard Deviation 1.35 |
| Placebo PBO/BMT | 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 | Open label extension | 0.10 events | Standard Deviation 1.189 |