Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
695 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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