Vaginal Atrophy Clinical Trial
Official title:
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
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.
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.
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