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A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis

NCT02995694 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 535

Last updated 2021-12-01

Study results available
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Summary

The purpose of this study is to determine the therapeutic equivalence of Alvogen'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.

Conditions

  • Atrophic Vaginitis

Interventions

DRUG

Estradiol

Estradiol Vaginal Cream

DRUG

Placebos

Placebo with no active pharmaceutical ingredients. Topical vaginal cream

DRUG

Reference

Estrace Vaginal Cream

Sponsors & Collaborators

  • Alvogen Pine Brook LLC

    lead INDUSTRY

Principal Investigators

  • Meena Venugopal, Ph.D. · Alvogen Pine Brook LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-12-31
Completion
2016-12-31

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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 NCT02995694 on ClinicalTrials.gov