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The purpose of this study is to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women with Hypoactive Sexual Desire Disorder(with or without Decreased Arousal).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bremelanotide | Experimental | Bremelanotide (BMT) subcutaneously (SC) via auto-injector for 8-weeks double-Blind period |
|
| Placebo | Placebo Comparator | Placebo subcutaneously (SC) via auto-injector for 4-weeks single-Blind period and for 8-weeks double-Blind period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bremelanotide | Drug | Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to End of Study in the desire domain from the FSFI | Baseline up to End of Study(8weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to End of Study in FSDS-DAO (Item 13) | Baseline up to End of Study(8weeks) | |
| Change from Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration | Baseline up to End of Study(8weeks) |
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[Main Inclusion Criteria]
[Main Exclusion Criteria]
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| Name | Affiliation | Role |
|---|---|---|
| Soo Woong Kim, Dr | Seoul National University Hospital | Principal Investigator |
| Tak Kim, Dr | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| Placebo | Drug | Subjects will self-administer a Placebo subcutaneously (SC) via auto-injector. |
|
| Change from Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R | Baseline up to End of Study(8weeks) |
| Change from Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R | Baseline up to End of Study(8weeks) |
| Change from Baseline to End of Study in the FSDS-DAO Total Score | Baseline up to End of Study(8weeks) |
| Change from Baseline to End of study in the total FSFI score based on the 19 questions | 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. | Baseline up to End of Study(8weeks) |
| Change in mean Level of Sexual Arousal from FSEP-R Q6 | Baseline up to End of Study(8weeks) |
| Change in mean Satisfaction with Sexual Arousal from FSEP-R Q7. | Baseline up to End of Study(8weeks) |
| Change from Baseline to End of study in the scored time spent being concerned by difficulty with sexual arousal as measured by the FSDS-DAO Q14. | Baseline up to End of Study(8weeks) |
| Change from Baseline to End of study in the arousal domain from the FSFI Q3 through Q6. | Baseline up to End of Study(8weeks) |
| Change from Baseline to End of study in the total number of SSEs. | Baseline up to End of Study(8weeks) |
| Change from baseline in the desire domain from the FSFI Q1 and Q2 using all available double-blind data (visit 4, 5) | Baseline up to End of Study(8weeks) |
| Change from baseline in the score for feeling bothered by low sexual desire as measured by the FSDS -DAO Q13 using all available double-blind data(visit 4, 5) | Baseline up to End of Study(8weeks) |
| Change from baseline in the number of SSEs associated with study drug using the entire 8 weeks of the double-blind phase. | Baseline up to End of Study(8weeks) |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C476721 | bremelanotide |
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