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

NCT03740945 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-07-31

No results posted yet for this study

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.

Conditions

  • Vaginal Atrophy in Breast Cancer Patients

Interventions

DRUG

Placebo

Daily administration of one placebo vaginal ovule at bedtime

DRUG

Prasterone (DHEA)

Daily administration of one prasterone vaginal ovule at bedtime

Sponsors & Collaborators

  • AMAG Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • EndoCeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Claude Labrie, M.D., Ph.D. · Endoceutics, Inc., Quebec, Canada

  • David F Archer, M.D. · Jones Institute, Norfolk VA 23507

  • Sheryl Kingsberg, Ph.D. · MacDonald Women's Hospital, Cleveland, OH 44106 USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2019-12-05
Completion
2019-12-05
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03740945 on ClinicalTrials.gov