Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy

Study Overview
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Brief Summary
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To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.

Conditions
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Atrophy

Intervention / Treatment
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* Drug: estrace cream (Perrigo)
* Drug: estrace cream (Reference)
* Drug: Placebo cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: postmenopausal female and otherwise healthy, 30 - 75 years of age. ≤ 5% superficial cells on vaginal smear cytology at Visit 1/Screening. vaginal pH > 5.0 at Visit 1/Screening Have at least one self-assessed moderate to severe symptom of Vulvar and Vaginal Atrophy identified by the subject as being the most bothersome For women with an intact uterus, vaginal ultrasonography confirmation at Visit 1/Screening of an inactive endometrial lining with an endometrial thickness less than 4 mm. Systolic blood pressure no greater than 150 mm Hg and diastolic blood pressure no greater than 90 mm Hg at Visit 1/Screening and at Visit 2/Randomization Exclusion Criteria: Undiagnosed vaginal bleeding or a history of significant risk factors for endometrial cancer. Known, suspected, or history of cancer of the breast or mammogram indicating any abnormalities or subject has a history of cervical cancer. Vaginal ultrasonography for all women with an intact uterus confirming endometrial thickness of 4mm or more History of hypersensitivity or allergy to estradiol or any of the other study medication ingredients. Known or suspected estrogen-dependent neoplasia. Has deep vein thrombosis, pulmonary embolism or history of these conditions. • Subject has active arterial thromboembolic disease (e. g. stroke, myocardial infarction) or history of these conditions. Known acute or chronic hepatic disease or dysfunction

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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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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Product<br>estradiol cream | Drug: estrace cream (Perrigo)<br> <br> * Other names: Perrigo product;|
| Active Comparator: Reference Product<br>estradiol cream | Drug: estrace cream (Reference)<br> <br> * Other names: Reference Listed Drug product;|
| Placebo Comparator: Placebo product<br>Placebo cream | Drug: Placebo cream<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Identified as Responders | A responder is a subject meeting specific vaginal cytology criteria AND a vaginal pH < 5.0 with a change from Visit 1 of at least 0.5. | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Most Bothersome Symptom | Percentage of subjects based on the improvement (change from Visit 2) of the Most Bothersome Symptom at Visit 3. | Day 8 |