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To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.

NCT02668796 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 522

Last updated 2017-11-14

No results posted yet for this study

Summary

This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.

Conditions

  • Vulvar and Vaginal Atrophy

Interventions

DRUG

Estradiol Vaginal Tablets 10 mcg (Glenmark)

apply using the given applicator

DRUG

Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)

apply using the given applicator

DRUG

Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)

apply using the given applicator

Sponsors & Collaborators

  • Glenmark Pharmaceuticals Ltd. India

    lead INDUSTRY

Principal Investigators

  • Dr. Nikhil Sawant · Glenmark Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-09-21
Completion
2016-09-21

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 NCT02668796 on ClinicalTrials.gov