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NCT02195986 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
366
Enrollment target

NCT02195986 is a Phase 3 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 366 participants.

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The verdict

NCT02195986, a Phase 3 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
366 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Estradiol Vaginal Cream, 0.01%
  • DRUG Estrace® 0.01% cream
  • DRUG Placebo Vaginal Cream

Trial Details

FieldValue
Enrollment Target 366 participants
Start Date 2014-06
Est. Completion 2014-12
Phase Phase 3

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT02195986

The ClinicalTrials.gov registry entry for NCT02195986 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 366 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Estradiol Vaginal Cream, 0.01% is the first listed.

NCT02195986 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02195986 about?

NCT02195986 is a clinical study titled "A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis". 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.

What is the current status of trial NCT02195986?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 366 participants. The study started on 2014-06. Estimated completion is 2014-12.

What interventions are being tested in trial NCT02195986?

The interventions under investigation include: Estradiol Vaginal Cream, 0.01% (DRUG), Estrace® 0.01% cream (DRUG), Placebo Vaginal Cream (DRUG).

Who is sponsoring clinical trial NCT02195986?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

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.