Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

• Status: Terminated
• Trial end date: 2013-04-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharmaceutical Industries Limited
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Postmenopausal woman

• At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy

• ≤ 5% superficial cells on vaginal smear cytology

• Vaginal pH > 5.0

Exclusion Criteria:

• Consumption of estrogen alone or estrogen/progestin containing drug products.

• Allergy to estradiol or related products

• History of breast cancer and significant risk factors for endometrial cancer

• Abnormal genital bleeding