To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.

Study Overview
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Brief Summary
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This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.

Official Title
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A Phase III Investigator-Blind, Randomized, Parallel-Group, Placebo- Controlled, Multicentre Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) Administered for 14 Days and Compare Both Active Treatments to a Placebo Control in Female Subjects With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated With Menopause.

Conditions
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Vulvar and Vaginal Atrophy

Intervention / Treatment
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* Drug: Estradiol Vaginal Tablets 10 mcg (Glenmark)
* Drug: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
* Drug: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female postmenopausal subjects aged >30 to <75 years At least 1 subject assessed moderate to severe symptom of vulvar and vaginal atrophy among the following that is identified as being the most bothersome to her vaginal dryness vaginal and/or vulvar irritation/ itching dysuria vaginal pain associated with sexual activity presence of vaginal bleeding associated with sexual activity Have <5% superficial cells on vaginal smear cytology and vaginal pH >5.0 at Visit 1 Systolic blood pressure <150mm Hg and diastolic blood pressure <90mm Hg at Visit 1 Exclusion Criteria: Known hypersensitivity to Estradiol vaginal tablet Screening mammogram or clinical breast examination results indicating any suspicion of breast malignancy. History of undiagnosed vaginal bleeding. History of significant risk factors for endometrial cancer For women with an intact uterus, screening vaginal ultrasonography showing endometrial thickness of ≥ 4 mm.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estradiol Vaginal Tablets 10 mcg (Glenmark)<br>apply using the given applicator | Drug: Estradiol Vaginal Tablets 10 mcg (Glenmark)<br>* apply using the given applicator<br>|
| Active Comparator: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)<br>apply using the given applicator | Drug: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)<br>* apply using the given applicator<br>|
| Placebo Comparator: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)<br>apply using the given applicator | Drug: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)<br>* apply using the given applicator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with at least 25% reduction from baseline in the sum of % basal/parabasal + %intermediate cells on vaginal cytology and vaginal pH <5.0 with a change from baseline vaginal pH of at least 0.5 |  | Day 15] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with treatment success at the end of study where treatment success is defined as a subject who achieves a score of 0 (none) or 1 (mild) at Visit 3/End of Study for the MBS |  | Day 15] |