Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer
- Conditions
- Vaginal Atrophy in Breast Cancer Patients
- Interventions
- Drug: Placebo
- Registration Number
- NCT03740945
- Lead Sponsor
- EndoCeutics Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prasterone Prasterone (DHEA) Prasterone (DHEA) vaginal ovule daily for 12 weeks Placebo Placebo Placebo vaginal ovule daily for 12 weeks
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 12 weeks 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.
Change from Baseline to Week 12 on subjective arousal domain of FSFI 12 weeks 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.
Change from Baseline to Week 12 on desire domain of FSFI 12 weeks 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.
Change from Baseline to Week 12 on satisfaction domain of FSFI 12 weeks 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.
Change from Baseline to Week 12 on orgasm domain of FSFI 12 weeks 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.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity 12 weeks Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions 12 weeks Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness 12 weeks Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color 12 weeks Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.