Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy
Postmenopausal Symptoms
About this trial
This is an interventional treatment trial for Postmenopausal Symptoms focused on measuring Post menopausal vasomotor symptoms
Eligibility Criteria
Inclusion Criteria: Women 45-65 years naturally or surgically postmenopausal experiencing hot flushes Exclusion Criteria: hypersensitivity to estrogen replacement therapy pregnancy or lactating abnormal PAP smear history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
EstroGel® Gel 0.9 grams 0.03%
EstroGel® Gel 1.25 grams 0.03%
Placebo Gel
0.9 g of EstroGel® 0.03% applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.
1.25 g of EstroGel® 0.03% applied to one arm and 0.9 g of placebo gel applied on the other arm once daily for 12 weeks.
0.9 g of placebo gel applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.