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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-06

Study Completion Date

2019-12-05

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.

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Detailed Description

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Conditions

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Vaginal Atrophy in Breast Cancer Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo vaginal ovule daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Daily administration of one placebo vaginal ovule at bedtime

Prasterone

Prasterone (DHEA) vaginal ovule daily for 12 weeks

Group Type EXPERIMENTAL

Prasterone (DHEA)

Intervention Type DRUG

Daily administration of one prasterone vaginal ovule at bedtime

Interventions

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Placebo

Daily administration of one placebo vaginal ovule at bedtime

Intervention Type DRUG

Prasterone (DHEA)

Daily administration of one prasterone vaginal ovule at bedtime

Intervention Type DRUG

Other Intervention Names

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Intrarosa

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No