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Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women

NCT02253173 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 764

Last updated 2017-05-25

Study results available
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Summary

This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.

Conditions

  • Vulvovaginal Atrophy
  • Menopause
  • Dyspareunia
  • Painful Intercourse

Interventions

DRUG

Estradiol

DRUG

Placebo

Sponsors & Collaborators

  • TherapeuticsMD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02253173 on ClinicalTrials.gov