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Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)

NCT01455597 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2022-05-09

Study results available
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Summary

This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.

Conditions

  • Vulvovaginal Atrophy

Interventions

DRUG

WC3011 Estradiol Vaginal Cream

WC3011 estradiol vaginal cream, 3 times a week for 40 weeks.

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Anna Chan, PharmD · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-20
Primary Completion
2012-12-03
Completion
2012-12-03
FDA Drug
Yes

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 NCT01455597 on ClinicalTrials.gov