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COMPLETED Phase 2

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

NCT02670785 · View on ClinicalTrials.gov ↗

Study Summary

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

Interventions

  • DRUG Placebo
  • DRUG Estradiol Vaginal Capsule (EVC)

Study Locations (20)

Florida

  • Women's Medical Research Group, LLC — Clearwater
  • Radiant Research, Inc. — Pinellas Park
  • Comprehensive Clinical Trials, LLC — West Palm Beach

North Carolina

  • Carolina Women's Research and Wellness Center — Durham
  • Hawthorne Medical Research, Inc. — Winston-Salem

Ohio

  • Rapid Medical Research, Inc. — Cleveland
  • Women's Health Research — Columbus

Texas

  • Radiant Research, Inc. — Dallas
  • Radiant Research, Inc. — San Antonio

Washington

  • Seattle Women's Health, Research, Gynecology — Seattle
  • North Spokane Women's Clinic — Spokane

Arizona

  • Visions Clinical Research-Tucson — Tucson

California

  • Genesis Center for Clinical Research — San Diego

Connecticut

  • Coastal Connecticut Research, LLC — New London

Trial Details

FieldValue
Enrollment Target 203 participants
Start Date 2016-02-15
Est. Completion 2016-11-14
Phase Phase 2

Sponsor

Warner Chilcott

18 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02670785

The ClinicalTrials.gov registry entry for NCT02670785 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 203 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Warner Chilcott, which has 18 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Menopause appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02670785 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Florida, North Carolina, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02670785 about?

NCT02670785 is a clinical study titled "A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy". This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.

What is the current status of trial NCT02670785?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 203 participants. The study started on 2016-02-15. Estimated completion is 2016-11-14.

What conditions does trial NCT02670785 study?

This clinical trial studies the following conditions: Menopause, Dyspareunia, Vulvovaginal Atrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02670785?

The interventions under investigation include: Placebo (DRUG), Estradiol Vaginal Capsule (EVC) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02670785?

This trial is sponsored by Warner Chilcott, which has 18 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02670785 being conducted?

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

Related

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