drugset / Trial / NCT02668796

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

NCT02668796

Phase 3 Completed 522 enrolled Glenmark Pharmaceuticals Ltd. India
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 10 ug Other