Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

Phase 3

Terminated

• Conditions: Vulvar Atrophy; Vaginal Atrophy
• Interventions: Drug: Estradiol

• Registration Number: NCT01753102
• Lead Sponsor: Sun Pharmaceutical Industries Limited

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 Timeline

• Study Start: 2012-11-06
• Study First Submitted: 2012-12-15
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-20
• Primary Completion: 2013-04-30
• Study Completion: 2013-04-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-06
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference: Estradiol	Estradiol	Intravaginal self-administration of study medication once daily for 14 days.
Placebo	Estradiol	Intravaginal self-administration of study medication once daily for 14 days.
Estradiol	Estradiol	Intravaginal self-administration of study medication once daily for 14 days.

Primary Outcome Measures

Name	Time	Method
Vaginal pH	14 days

Secondary Outcome Measures

Name	Time	Method
Symptoms of vulvar and vaginal atrophy	14 days	Each subject will specify identified most bothersome symptoms vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity, vaginal bleeding associated with sexual activity) and self-evaluate the symptom on a pre-defined scale

Trial Locations

Locations (1)

Biniwale Clinic Pvt. Ltd,; 🇮🇳 Pune, Maharashtra, India