Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vulvar Atrophy, Vaginal Atrophy

Intervention / Treatment
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* Drug: Estradiol


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estradiol<br>Intravaginal self-administration of study medication once daily for 14 days. | Drug: Estradiol<br>* one tablet will be inserted daily for 14 days<br>* Other names: Vagifem;|
| Active Comparator: Reference: Estradiol<br>Intravaginal self-administration of study medication once daily for 14 days. | Drug: Estradiol<br>* one tablet will be inserted daily for 14 days<br>* Other names: Vagifem;|
| Placebo Comparator: Placebo<br>Intravaginal self-administration of study medication once daily for 14 days. | Drug: Estradiol<br>* one tablet will be inserted daily for 14 days<br>* Other names: Vagifem;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal pH |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of vulvar and vaginal atrophy | 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 | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Estradiol, Vulvar atrophy, vaginal atrophy