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Clinical trialNCT02195986CompletedPhase 3Interventional

A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis

SponsorMylan Pharmaceuticals IncEnrollment366Atrophic Vaginitis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Ara-Arizona Research Associates

    Tucson, Arizona, United States

  • Axis Clinical Trials

    Los Angeles, California, United States

  • Northern Ca Research

    Sacramento, California, United States

  • Mccr

    San Diego, California, United States

  • Women'S Health Care Research Corp.

    San Diego, California, United States

  • Mcb Clinical Research Centers

    Colorado Springs, Colorado, United States

  • Downtown Women'S Health Care

    Denver, Colorado, United States

  • Horizons Clinical Research Center, Llc

    Denver, Colorado, United States

  • Sunrise Medical Research

    Coral Springs, Florida, United States

  • Health Awareness, Inc.

    Jupiter, Florida, United States

  • Meridien Research

    Lakeland, Florida, United States

  • Ob-Gyn Associates of Mid Florida

    Leesburg, Florida, United States

  • Southcoast Research Center

    Miami, Florida, United States

  • Veritas Research, Corp.

    Miami Lakes, Florida, United States

  • Physician Care Clinical Research Llc

    Sarasota, Florida, United States

  • Meridien Research

    St. Petersburg, Florida, United States

  • Sunrise Medical Research

    Tamarac, Florida, United States

  • Comprehensive Clinical Trials, Llc

    West Palm Beach, Florida, United States

  • Georgia Center for Women

    Atlanta, Georgia, United States

  • Lawrence Ob/gyn Clinical Research, Llc

    Lawrenceville, New Jersey, United States

  • Women'S Health Research Center/the Center for Women'S Health & Wellness, Llc

    Plainsboro, New Jersey, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Estrace® 0.01% creamEstradiolPlacebo Vaginal Cream
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Jun 2014
Primary completion
31 Dec 2014
Completion
31 Dec 2014
Last update posted
9 Mar 2022
Registered enrollment
366
Registry id
NCT02195986

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.