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

This is an interventional treatment trial for Atrophy Read More

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