Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced menopause, in women with breast cancer who are under treatment with an aromatase inhibitor.

Official Title
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Effect of Intravaginal Prasterone (DHEA) on Moderate to Severe Symptoms of Vulvovaginal Atrophy Due to Menopause, in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer - (Placebo-Controlled, Double Blind and Randomized Phase III Study)

Conditions
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Vaginal Atrophy in Breast Cancer Patients

Intervention / Treatment
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* Drug: Placebo
* Drug: Prasterone (DHEA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Main criteria: Natural, surgically- or treatment-induced postmenopausal women (non hysterectomized or hysterectomized) with breast cancer (stage 1 or 2) who is currently under treatment with an aromatase inhibitor and will remain on that treatment for the duration of the study. Women between 30 and 80 years of age Women having ≤5% of superficial cells on vaginal smear at baseline Women having a vaginal pH above 5 at baseline Women who have self-identified moderate or severe symptom(s) of vaginal atrophy Exclusion Criteria: Main criteria: Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication The administration of any investigational drug within 30 days of screening visit

Ages Eligible for Study
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Minimum Age: 30 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>Placebo vaginal ovule daily for 12 weeks | Drug: Placebo<br>* Daily administration of one placebo vaginal ovule at bedtime<br>|
| Experimental: Prasterone<br>Prasterone (DHEA) vaginal ovule daily for 12 weeks | Drug: Prasterone (DHEA)<br>* Daily administration of one prasterone vaginal ovule at bedtime<br>* Other names: Intrarosa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 12 in the Percentage of Superficial Cells |  | 12 weeks | 
| Change from Baseline to Week 12 in the Percentage of Parabasal Cells |  | 12 weeks | 
| Change from Baseline to Week 12 in Vaginal pH |  | 12 weeks | 
| Change from Baseline to Week 12 in Moderate/Severe VVA symptom being Most Bothersome (MBS) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 12 in Moderate/Severe VVA symptom (not most bothersome) |  | 12 weeks | 
| Change from Baseline to Week 12 on arousal/lubrication domain of Female Sexual Function Index (FSFI) questionnaire | Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor. | 12 weeks | 
| Change from Baseline to Week 12 on subjective arousal domain of FSFI | Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor. | 12 weeks | 
| Change from Baseline to Week 12 on desire domain of FSFI | Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor. | 12 weeks | 
| Change from Baseline to Week 12 on satisfaction domain of FSFI | Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor. | 12 weeks | 
| Change from Baseline to Week 12 on orgasm domain of FSFI | Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor. | 12 weeks | 
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy. | 12 weeks | 
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy. | 12 weeks | 
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy. | 12 weeks | 
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vulvovaginal atrophy (VVA), Vaginal atrophy, Atrophic vaginitis, Prasterone, DHEA, Intrarosa, Breast cancer, Aromatase inhibitor