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Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy

NCT03332303 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2024-05-30

Study results available
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Summary

The objectives of this study are to evaluate the therapeutic equivalence of the Test formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients with vulvar and vaginal atrophy, and compare the safety of Test, Reference and Placebo treatments in patients with vulvar and vaginal atrophy.

Conditions

  • Vulvar and Vaginal Atrophy

Interventions

DRUG

Estrace® Cream

Estrace® Cream

DRUG

Estradiol Vaginal Cream

Estradiol Vaginal Cream

DRUG

Vehicle Cream

Vehicle Cream

Sponsors & Collaborators

  • Prasco LLC

    lead INDUSTRY

Principal Investigators

  • Gail Gongas · Novum

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
2017-10-26
Primary Completion
2018-03-15
Completion
2018-03-15
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 NCT03332303 on ClinicalTrials.gov