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)

EndoCeutics Inc.0 sitesNovember 6, 2018

ConditionsVaginal Atrophy in Breast Cancer Patients

InterventionsPlacebo Prasterone (DHEA)

DrugsPlacebo Prasterone (DHEA)

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Vaginal Atrophy in Breast Cancer Patients
Sponsor: EndoCeutics Inc.
Primary Endpoint: Change from Baseline to Week 12 in the Percentage of Superficial Cells
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 6, 2018

End Date

December 5, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

EndoCeutics Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Placebo

Placebo vaginal ovule daily for 12 weeks

Intervention: Placebo

Prasterone

Prasterone (DHEA) vaginal ovule daily for 12 weeks

Intervention: Prasterone (DHEA)

Outcomes

Primary Outcomes

Change from Baseline to Week 12 in the Percentage of Superficial Cells

Time Frame: 12 weeks

Change from Baseline to Week 12 in the Percentage of Parabasal Cells

Time Frame: 12 weeks

Change from Baseline to Week 12 in Vaginal pH

Time Frame: 12 weeks

Change from Baseline to Week 12 in Moderate/Severe VVA symptom being Most Bothersome (MBS)

Time Frame: 12 weeks

Secondary Outcomes

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)
Change from Baseline to Week 12 on subjective arousal domain of FSFI(12 weeks)
Change from Baseline to Week 12 on desire domain of FSFI(12 weeks)
Change from Baseline to Week 12 on satisfaction domain of FSFI(12 weeks)
Change from Baseline to Week 12 on orgasm domain of FSFI(12 weeks)
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions(12 weeks)
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness(12 weeks)
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity(12 weeks)
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color(12 weeks)