Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

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.

Timeline

Start

2012-11-06

Primary completion

2013-04-30

Completion

2013-04-30

Drugs

Indications