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A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy

NCT02670785 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2017-08-23

No results posted yet for this study

Summary

This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.

Conditions

Interventions

DRUG

Estradiol Vaginal Capsule (EVC)

Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks

DRUG

Placebo

Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Vilma Sniukiene, MD · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-15
Primary Completion
2016-11-14
Completion
2016-11-14
FDA Drug
Yes

Countries

  • United States

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 NCT02670785 on ClinicalTrials.gov