Trial | NCT03740945  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
Study Started
Nov 06
2018
Primary Completion
Dec 05
2019
Study Completion
Dec 05
2019
Last Update
Jul 31
2020

Drug Placebo

Daily administration of one placebo vaginal ovule at bedtime

Drug Prasterone (DHEA)

Daily administration of one prasterone vaginal ovule at bedtime

  • Other names: Intrarosa

Placebo Placebo Comparator

Placebo vaginal ovule daily for 12 weeks

Prasterone Experimental

Prasterone (DHEA) vaginal ovule daily for 12 weeks

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
No Results Posted