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Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia

NCT01845649 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2022-05-09

Study results available
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Summary

The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.

Conditions

  • Vulvovaginal Atrophy

Interventions

DRUG

WC3011 Estradiol Vaginal Cream

Daily for 14 days followed by 3 times per week for 10 weeks

DRUG

Vehicle

Daily for 14 days followed by 3 times per week for 10 weeks

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Anna Chan, PharmD · Warner Chilcott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-12
Primary Completion
2013-11-20
Completion
2013-11-20

Countries

  • United States

Study Locations

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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 NCT01845649 on ClinicalTrials.gov