NCT01753102

Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

EFFICACY AND SAFETY OF SPIL'S ESTRADIOL VAGINAL TABLET, 10 MCG ESTRADIOL IN SUBJECTS WITH VULVAR AND VAGINAL ATROPHY: A RANDOMIZED, OBSERVER BLIND, PARALLEL GROUPS, ACTIVE AND PLACEBO CONTROLLED, CLINICAL ENDPOINT BIOEQUIVALENCE STUDY

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol. The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen. The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is approved and marketed in the US.

Detailed description

Estradiol vaginal tablet is indicated for use in the treatment of symptoms of atrophic vaginitis due to estrogen deficiency. This is a randomized, observer blind, parallel groups, active and placebo controlled study to test the clinical endpoint bioequivalence of test product (Estradiol vaginal tablet, 10mcg of Sun Pharmaceutical Industries Ltd. India) relative to reference (Vagifem®, Estradiol vaginal tablet, 10mcg estradiol of Novo Nordisk) in treatment of vulvar and vaginal atrophy. The patients will be administered with one tablet intravaginally daily for 14 days.

Conditions

• Vulvar Atrophy
• Vaginal Atrophy

Interventions

Type	Name	Description
DRUG	Estradiol	one tablet will be inserted daily for 14 days

Timeline

• Start date: 2012-11-06
• Primary completion: 2013-04-30
• Completion: 2013-04-30
• First posted: 2012-12-20
• Last updated: 2018-10-09

Locations

1 site across 1 country: India