Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study

Study Overview
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Brief Summary
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The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.

Official Title
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Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study (Placebo-Controlled, Double-Blind and Randomized Phase III Study of Intravaginal Prasterone)

Conditions
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Hypoactive Sexual Desire Disorder (HSDD)

Intervention / Treatment
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* Drug: Placebo Vaginal Insert
* Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (main criteria): Postmenopausal women (hysterectomized or not). Women between 40 and 80 years of age. Being in a stable relationship with the opportunity for sexual activity or masturbation at least once a month during the last 6 months or longer (before screening visit) and during the following 8 months. Diagnosis of HSDD confirmed by a qualified clinician. Willing to participate in the study and sign an informed consent. Exclusion Criteria (main criteria): Chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity. Taking drugs which could be responsible for HSDD. Severe medical condition which can explain the loss of sexual desire. The administration of any investigational drug within 30 days of screening visit. Clinically significant abnormal serum biochemistry, urinalysis or hematology.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo Vaginal Insert<br>* Daily administration of a placebo vaginal insert.<br>|
| Active Comparator: Prasterone<br> | Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert<br>* Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual desire | Change from Baseline in sexual desire as evaluated by Questions 1 & 2 of the 19-items questionnaire titled Female Sexual Function Index (FSFI). For this outcome, Question 1 and Question 2 (corresponding to the desire domain) will be graded from 1 to 5 (score range) and then be multiplied by 0.6 (domain factor). The desire domain (sum of scores from Questions 1 & 2) has a minimum score of 1.2 and a maximum score of 6. Higher values represent a better outcome. | 28 weeks | 
| Distress from low sexual desire | Change from Baseline in distress from low sexual desire as evaluated by Question 13 of the 15-items questionnaire titled Female Sexual Distress Scale - Desire Arousal Orgasm (FSDS-DAO). For this outcome, Question 13 is graded from 0 to 4 and a lower value represents a better outcome. | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfying sexual events (SSEs) | Change from Baseline in the number of SSEs from a daily log of sexual activity. | 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prasterone, DHEA, Menopause, Sexual Disorder, HSDD