A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)

Study Overview
=================
Brief Summary
-----------------
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).

Official Title
-----------------
A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)

Conditions
-----------------
Hypoactive Sexual Desire Disorder

Intervention / Treatment
-----------------
* Drug: Bremelanotide
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bremelanotide<br>Bremelanotide (BMT) subcutaneously (SC) via auto-injector for 8-weeks double-Blind period | Drug: Bremelanotide<br>* Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector.<br>|
| Placebo Comparator: Placebo<br>Placebo subcutaneously (SC) via auto-injector for 4-weeks single-Blind period and for 8-weeks double-Blind period | Drug: Placebo<br>* Subjects will self-administer a Placebo subcutaneously (SC) via auto-injector.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
KD-BMT-301, Bremelanotide