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Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis

NCT03294538 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 663

Last updated 2019-12-26

Study results available
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Summary

The objectives of this study were to evaluate the therapeutic equivalence of the Test formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva Pharmaceuticals, United States of America) to the marketed product, Estrace® Cream estradiol vaginal cream USP, 0.01% (Warner Chilcott) in participants with atrophic vaginitis; to demonstrate the superiority of the Test and Reference (active) treatments over Placebo (vehicle) cream in participants with atrophic vaginitis; and to compare the safety of Test, Reference, and Placebo treatments in participants with atrophic vaginitis.

Conditions

  • Atrophic Vaginitis

Interventions

DRUG

Generic Estradiol Vaginal Cream USP, 0.01%

Vaginal cream, generic formulation of the brand product.

DRUG

Estrace® Vaginal Cream USP, 0.01%

Vaginal cream, brand product.

DRUG

Vehicle Vaginal Cream

Vaginal cream, placebo. Has no active ingredient

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Teva Pharmaceuticals USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-18
Primary Completion
2017-02-15
Completion
2017-02-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03294538 on ClinicalTrials.gov