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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Padagis LLC; Perrigo Company
• Collaborators: IMPAX Laboratories, Inc.; Impax Laboratories, LLC
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

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