Hypoactive Sexual Desire Disorder
Conditions
Keywords
HSDD Female, Sexual Desire Disorder, decreased desire, female sexual dysfunction
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)
DRUGPlacebo
Placebo
Sponsors
AMAG Pharmaceuticals, Inc.
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 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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. |
| 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. |
| 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. |
| 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. |
| 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) | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | Female Sexual Function Index (FSFI) The score is computed programmatically using the algorithm described by Rosen, resulting in a score ranging from 1.2 to 6. Higher 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 the Change in 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. A higher number of events indicates a better outcome. |
| 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 | 24 weeks (Main Study) | FSFI = Female Sexual Function Index The score is on a scale ranging from 1.2 to 6. A higher score on this scale represents an increase in sexual desire and is a better outcome. |
| 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 | 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). Decreased scores indicate improvement. A higher score indicates a worse outcome. |
| 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 | 24 weeks (Main Study) | Mean change from Baseline to EOS in the number of satisfying sexual events SSEs associated with study drug administration throughout the entirety of the double-blind phase. A higher number of events indicates a better outcome. |
| 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. |
| 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. |
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: 703 participants enrolled, 89 run-in failures 614 participants were randomized. OLE Study (optional): Of the 392 completers of the Core study, 321 participants enrolled in optional OLE study. The OLE Study was not reported.
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) | 303 |
| 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) | 301 |
| Total | 604 |
Baseline characteristics
| Characteristic | Bremelanotide (BMT/BMT) | Placebo (PBO/BMT) | Total |
|---|---|---|---|
| Age, Continuous Main | 38.5 years STANDARD_DEVIATION 7.19 | 39.1 years STANDARD_DEVIATION 6.96 | 38.8 years STANDARD_DEVIATION 7.08 |
| Age, Continuous OLE | 39.8 years STANDARD_DEVIATION 7.12 | 39.4 years STANDARD_DEVIATION 6.54 | 39.6 years STANDARD_DEVIATION 6.77 |
| Ethnicity (NIH/OMB) Main Hispanic or Latino | 21 Participants | 21 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Main Not Hispanic or Latino | 282 Participants | 280 Participants | 562 Participants |
| Ethnicity (NIH/OMB) Main Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) OLE Hispanic or Latino | 6 Participants | 9 Participants | 15 Participants |
| Ethnicity (NIH/OMB) OLE Not Hispanic or Latino | 124 Participants | 182 Participants | 306 Participants |
| Ethnicity (NIH/OMB) OLE Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Main American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Main Asian | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Main Black or African American | 29 Participants | 29 Participants | 58 Participants |
| Race (NIH/OMB) Main More than one race | 3 Participants | 2 Participants | 5 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 | 3 Participants | 4 Participants |
| Race (NIH/OMB) Main White | 263 Participants | 262 Participants | 525 Participants |
| Race (NIH/OMB) OLE American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) OLE Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) OLE Black or African American | 10 Participants | 15 Participants | 25 Participants |
| Race (NIH/OMB) OLE More than one race | 2 Participants | 2 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 | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) OLE White | 117 Participants | 171 Participants | 288 Participants |
| Sex: Female, Male Main Female | 303 Participants | 301 Participants | 604 Participants |
| Sex: Female, Male Main Male | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male OLE Female | 130 Participants | 191 Participants | 321 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 / 303 | 0 / 301 | 0 / 130 | 0 / 191 |
| other Total, other adverse events | 224 / 303 | 137 / 301 | 93 / 130 | 142 / 191 |
| serious Total, serious adverse events | 3 / 303 | 2 / 301 | 1 / 130 | 0 / 191 |
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 (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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: A total 321 of the 392 (81.9%) 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 | -0.71 score on a scale | Standard Deviation 1.145 |
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | Open label extension | -1.4 score on a scale | Standard Deviation 1.2 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) | Main study | -0.42 score on a scale | Standard Deviation 1.047 |
| 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 1.07 |
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 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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: A total 321 of the 392 (81.9%) 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 FSFI (Question Q1 and Q2), 28-day Recall. | Main study | 0.63 score on a scale | Standard Deviation 1.036 |
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. | Open label extension | 1.25 score on a scale | Standard Deviation 1.158 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. | Main study | 0.21 score on a scale | Standard Deviation 0.922 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. | Open label extension | 0.70 score on a scale | Standard Deviation 1.22 |
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
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| 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 (EOS) in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration | Main study | 0.0 events | Standard Deviation 1.34 |
| Bremelanotide BMT/BMT | 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 | Open label extension | 0.19 events | Standard Deviation 1.997 |
| Placebo PBO/BMT | 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 | Main study | 0.0 events | Standard Deviation 1.2 |
| Placebo PBO/BMT | 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 | Open label extension | -0.31 events | Standard Deviation 1.296 |
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
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| 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 Mean Desire Score (Q3) From the FSEP-R | Open label extension | 0.43 score on a scale | Standard Deviation 1.095 |
| Bremelanotide BMT/BMT | 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 | Main study | 0.04 score on a scale | Standard Deviation 1.065 |
| Placebo PBO/BMT | 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 | Main study | 0.01 score on a scale | Standard Deviation 0.928 |
| Placebo PBO/BMT | 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 | Open label extension | 0.33 score on a scale | Standard Deviation 1.023 |
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
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| 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 Mean Satisfaction With Desire Score (Q4) From FSEP-R | Main study | 0.27 score on a scale | Standard Deviation 1.077 |
| Bremelanotide BMT/BMT | 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 | Open label extension | 0.76 score on a scale | Standard Deviation 1.127 |
| Placebo PBO/BMT | 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 | Main study | 0.11 score on a scale | Standard Deviation 0.977 |
| Placebo PBO/BMT | 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 | Open label extension | 0.47 score on a scale | Standard Deviation 1.075 |
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)
Female Sexual Function Index (FSFI) The score is computed programmatically using the algorithm described by Rosen, resulting in a score ranging from 1.2 to 6. Higher 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 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.
| 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 Arousal Domain of the FSFI (Q3 to Q6) | Main study | 0.52 score on a scale | Standard Deviation 1.535 |
| Bremelanotide BMT/BMT | 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) | Open label extension | 1.19 score on a scale | Standard Deviation 1.56 |
| Placebo PBO/BMT | 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) | Main study | 0.18 score on a scale | Standard Deviation 1.254 |
| Placebo PBO/BMT | 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) | Open label extension | 0.83 score on a scale | Standard Deviation 1.563 |
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
FSFI = Female Sexual Function Index The score is on a scale ranging from 1.2 to 6. A higher score on this scale represents an increase in sexual desire and is a better outcome.
Time frame: 24 weeks (Main Study)
Population: Completed double-blind study of Main study. 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 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 score on a scale | Standard Deviation 1.052 |
| Placebo PBO/BMT | 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 | 0.16 score on a scale | Standard Deviation 0.909 |
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
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)
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| 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 FSDS-DAO Total Score | Main study | -9.7 score on a scale | Standard Deviation 13.79 |
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSDS-DAO Total Score | Open label extension | -18.4 score on a scale | Standard Deviation 14.06 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSDS-DAO Total Score | Main study | -5.6 score on a scale | Standard Deviation 12.06 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSDS-DAO Total Score | Open label extension | -11.1 score on a scale | Standard Deviation 14.37 |
Secondary
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| 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 FSFI Total Score | Main study | 2.45 score on a scale | Standard Deviation 7.383 |
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score | Open label extension | 5.15 score on a scale | Standard Deviation 7.301 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score | Open label extension | 3.14 score on a scale | Standard Deviation 7.281 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score | Main study | 0.84 score on a scale | Standard Deviation 5.879 |
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
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| 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 Mean Level of Sexual Arousal (Q6) From the FSEP-R | Main study | 0.04 score on a scale | Standard Deviation 1.068 |
| Bremelanotide BMT/BMT | 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 | Open label extension | 0.33 score on a scale | Standard Deviation 0.987 |
| Placebo PBO/BMT | 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 | Main study | -0.01 score on a scale | Standard Deviation 0.906 |
| Placebo PBO/BMT | 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 | Open label extension | 0.35 score on a scale | Standard Deviation 0.994 |
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
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| 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 Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R | Main study | 0.23 score on a scale | Standard Deviation 1.112 |
| Bremelanotide BMT/BMT | 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 | Open label extension | 0.60 score on a scale | Standard Deviation 1.107 |
| Placebo PBO/BMT | 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 | Main study | 0.09 score on a scale | Standard Deviation 0.974 |
| Placebo PBO/BMT | 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 | Open label extension | 0.47 score on a scale | Standard Deviation 1.102 |
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
Mean change from Baseline to EOS in the number of satisfying sexual events SSEs associated with study drug administration throughout the entirety of the double-blind phase. A higher number of events indicates a better outcome.
Time frame: 24 weeks (Main Study)
Population: Completed double-blind study of Main study. OLE study wan not a double blind study.
| Arm | Measure | 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 SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase | 0.1 events | Standard Deviation 1.37 |
| 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 SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase | -0.1 events | Standard Deviation 1.28 |
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
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.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| 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 Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO | Main study | -0.8 score on a scale | Standard Deviation 1.23 |
| Bremelanotide BMT/BMT | 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 | Open label extension | -1.3 score on a scale | Standard Deviation 1.11 |
| Placebo PBO/BMT | 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 | Main study | -0.4 score on a scale | Standard Deviation 1.11 |
| Placebo PBO/BMT | 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 | Open label extension | -0.9 score on a scale | Standard Deviation 1.17 |
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
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). Decreased scores indicate improvement. A higher score indicates a worse outcome.
Time frame: 24 weeks (Main Study)
Population: Completed double-blind study of Main study. OLE study wan not a double blind study.
| Arm | Measure | 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 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 score on a scale | Standard Deviation 1.22 |
| Placebo PBO/BMT | 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 | -0.4 score on a scale | Standard Deviation 1.02 |
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
Change from Baseline to EOS in the total number of satisfying sexual events SSEs. A higher number of events indicates a better outcome.
Time frame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Population: 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.
| 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 Total Number of SSEs | Main study | 0.0 events | Standard Deviation 1.34 |
| Bremelanotide BMT/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Total Number of SSEs | Open label extension | 0.25 events | Standard Deviation 2.376 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Total Number of SSEs | Main study | -0.0 events | Standard Deviation 1.2 |
| Placebo PBO/BMT | Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Total Number of SSEs | Open label extension | -0.35 events | Standard Deviation 1.655 |