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NCT01455597 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Vulvovaginal Atrophy, sponsored by Warner Chilcott.

Completed
Registry status
Phase 3
Development phase
309
Enrollment target
20
Study locations

NCT01455597 is a Phase 3 study of Vulvovaginal Atrophy that has completed, run by Warner Chilcott. The registered enrollment target is 309 participants. The trial reports 20 study locations across 5 states.

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The verdict

NCT01455597, a Phase 3 study of Vulvovaginal Atrophy, has completed, sponsored by Warner Chilcott.

COMPLETED
Registry status
Phase 3
Development phase
309 participants
Enrollment target
20
Study locations

Study 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 Studied

Interventions

  • DRUG WC3011 Estradiol Vaginal Cream

Study Locations (20)

Florida

  • Visions Clinical Research - Boynton Beach
  • Women's Medical Research Group, LLC - Clearwater
  • Jacksonville Center for Clinical Research - Jacksonville
  • Miami Research Associates - Miami
  • New Age Medical Research Corp - Miami
  • Ormond Medical Arts Pharmaceutical Research Center - Ormond Beach
  • OB-GYN Specialists of the Palm Beaches - Palm Beach Gardens
  • Radiant Research-St. Petersburg - Pinellas Park
  • Comprehensive Clinical Trials, LLC - West Palm Beach

Arizona

  • Women's Health Research - Phoenix
  • Precision Trials, LLC - Phoenix
  • Radiant Research-Scottsdale - Scottsdale
  • Radiant Research-Tucson - Tucson
  • Visions Clinical Research-Tucson - Tucson

California

  • Genesis Center for Clinical Research - San Diego
  • Medical Center for Clinical Research - San Diego
  • Women's Healthcare Inc. - San Diego

Alabama

  • Medical Affiliated Research Center, Inc. - Huntsville
  • Warner Chilcott Investigational Site - Mobile

Connecticut

  • Coastal Connecticut Research, LLC - New London

Trial Details

FieldValue
Enrollment Target 309 participants
Start Date 2011-10-20
Est. Completion 2012-12-03
Phase Phase 3

Sponsor

Warner Chilcott

53 total trials

What the Registry Record Tells You About NCT01455597

The ClinicalTrials.gov registry entry for NCT01455597 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 309 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Warner Chilcott, which has 53 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Vulvovaginal Atrophy appearing as the primary indexed condition, and to 1 intervention - of which WC3011 Estradiol Vaginal Cream is the first listed.

NCT01455597 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT01455597 about?

NCT01455597 is a clinical study titled "Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)". 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.

What is the current status of trial NCT01455597?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 2011-10-20. Estimated completion is 2012-12-03.

What conditions does trial NCT01455597 study?

This clinical trial studies the following conditions: Vulvovaginal Atrophy.

What interventions are being tested in trial NCT01455597?

The interventions under investigation include: WC3011 Estradiol Vaginal Cream (DRUG).

Who is sponsoring clinical trial NCT01455597?

This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01455597 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.