Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-25 @ 3:40 AM
NCT ID:
NCT01753102
Brief 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.
Study:
NCT01753102
Study Brief:
Protocol Section:
NCT01753102