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Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy

NCT02770365 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 695

Last updated 2021-11-02

Study results available
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Summary

To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.

Conditions

  • Atrophy

Interventions

DRUG

estrace cream (Perrigo)

DRUG

estrace cream (Reference)

DRUG

Placebo cream

Sponsors & Collaborators

  • Impax Laboratories, LLC

    collaborator INDUSTRY

  • Padagis LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-11-30
Completion
2016-11-30

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 NCT02770365 on ClinicalTrials.gov