Completed

A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women

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What is being tested

Vehicle

+ WC3011 Estradiol Vaginal Cream

Drug
Who is being recruted

Over 35 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorWarner Chilcott
Last updated: May 9, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: January 31, 2013

Actual date on which the first participant was enrolled.

The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and vaginal smear.

NCT01816139
Principal SponsorWarner Chilcott
Last updated: May 9, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

576 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
Age >= 40 years or if bilateral oophorectomy >= 35 years
Less than or equal 5% superficial cells on vaginal wall cytologic smear
Moderate to severe vaginal dryness
Normal breast exam; if > 40 years, documentation of negative mammogram
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8 exclusion criteria prevent from participating
Cardiovascular disease, insulin-dependent diabetes mellitus, congestive heart failure, stroke or ischemic attack, thrombophlebitis or thromboembolic disorder
Currently taking St. John's Wort or anticoagulant
Drug addiction/alcohol abuse within last 2 years
Increased frequency/severity headaches with estrogen therapy
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.

Group II

Placebo
WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 48 locations

Warner Chilcott Investigational Study Site

Huntsville, United StatesOpen Warner Chilcott Investigational Study Site in Google Maps

Warner Chilcott Investigational Study Site

Mobile, United States

Warner Chilcott Investigational Study Site

Phoenix, United States

Warner Chilcott Investigational Study Site

Scottsdale, United States
Completed48 Study Centers