| 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. | A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. | Posted | | Mean | Standard Deviation | score on a scale | | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT/BMT | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO/BMT | (Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) |
| | | Title | Denominators | Categories |
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| Main study | - ParticipantsOG000282
- ParticipantsOG001288
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| 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. | A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. | Posted | | Mean | Standard Deviation | score on a scale | | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT/BMT | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO/BMT | (Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) |
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| 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. | 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. | Posted | | Mean | Standard Deviation | events | | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT/BMT | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO/BMT | (Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT/BMT | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO/BMT | (Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT/BMT | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO/BMT | (Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) |
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| 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) | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT/BMT | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO/BMT |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT/BMT | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO/BMT | (Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT/BMT | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO/BMT | (Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT/BMT | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO/BMT | (Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT/BMT | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO/BMT | (Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT/BMT | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO/BMT | (Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) |
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| 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. | 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. | Posted | | Mean | Standard Deviation | events | | 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT/BMT | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO/BMT | (Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) |
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| 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. | Completed double-blind study of Main study. OLE study was not a double blind study. | Posted | | Mean | Standard Deviation | score on a scale | | 24 weeks (Main Study) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT | (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO | Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours. Placebo: Placebo |
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| 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. | Completed double-blind study of Main study. OLE study wan not a double blind study. | Posted | | Mean | Standard Deviation | score on a scale | | 24 weeks (Main Study) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT | (Main Study) 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. Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO | Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours. Placebo: Placebo |
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| 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. | Completed double-blind study of Main study. OLE study wan not a double blind study. | Posted | | Mean | Standard Deviation | events | | 24 weeks (Main Study) | | | | ID | Title | Description |
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| OG000 | Bremelanotide BMT | (Main Study) 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. Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | | OG001 | Placebo PBO | Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours. Placebo: Placebo |
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