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Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women

NCT01400776 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 722

Last updated 2022-05-09

Study results available
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Summary

Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.

Conditions

  • Postmenopausal Vulvovaginal Atrophy

Interventions

DRUG

WC3011 Estradiol Vaginal Cream

WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks

DRUG

Vehicle

Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Anna Chan, PharmD · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-29
Primary Completion
2012-02-27
Completion
2012-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01400776 on ClinicalTrials.gov