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

Phase 3

Withdrawn

• Conditions: Vaginal Atrophy in Breast Cancer Patients
• Interventions: Drug: Prasterone (DHEA); 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

Study Timeline

• Study Start: 2018-11-06
• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-10
• Study First Posted: 2018-11-14
• Primary Completion: 2019-12-05
• Study Completion: 2019-12-05
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Main criteria:

1. 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.
2. Women between 30 and 80 years of age
3. Women having ≤5% of superficial cells on vaginal smear at baseline
4. Women having a vaginal pH above 5 at baseline
5. Women who have self-identified moderate or severe symptom(s) of vaginal atrophy

Exclusion Criteria

Main criteria:

1. Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
2. 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 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 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 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.