NCT02668796

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

A Phase III Investigator-Blind, Randomized, Parallel-Group, Placebo- Controlled, Multicentre Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) Administered for 14 Days and Compare Both Active Treatments to a Placebo Control in Female Subjects With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated With Menopause.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 522 (actual)
• Sponsor: Glenmark Pharmaceuticals Ltd. India · Industry
• Sex: Female
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-09-21
• Completion: 2016-09-21
• First posted: 2016-01-29
• Last updated: 2017-11-14

Locations

1 site across 1 country: United States