NCT02770365CompletedPhase 3
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Padagis LLC
- Enrollment
- 695
- Locations
- 1
- Primary Endpoint
- Percentage of Subjects Identified as Responders
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Test Product
Experimental
estradiol cream
Intervention: estrace cream (Perrigo) (Drug)
Reference Product
Active Comparator
estradiol cream
Intervention: estrace cream (Reference) (Drug)
Placebo product
Placebo Comparator
Placebo cream
Intervention: Placebo cream (Drug)
Outcomes
Primary Outcomes
Percentage of Subjects Identified as Responders
Time Frame: Day 8
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.
Secondary Outcomes
- Most Bothersome Symptom(Day 8)
Investigators
Study Sites (1)
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