Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
Status:
Terminated
Trial end date:
2013-04-30
Target enrollment:
Participant gender:
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.