Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms

Phase III, Multicenter, Double-Blind Study of the Safety and Efficacy of Bio-E-Gel (Topical Estradiol Gel) Versus Placebo for Treatment of Vasomotor Symptoms and Vulvovaginal Atrophy in Postmenopausal Females

The purpose of this study is to determine the efficacy and safety of a topical estradiol gel for the treatment of hot flushes in postmenopausal women.

Estrogens are a group of hormones that play an important role in normal sexual and reproductive development in women. Estrogens serve many functions in the body. They stimulate oocyte maturation and endometrial growth, decrease bone resorption, initiate the development of secondary sex characteristics, maintain reproductive organs and glands, and affect the activity of the central nervous system. At menopause, the decrease in estrogen concentrations is often accompanied by vascular instability (hot flushes and night sweats), a rise in the incidence of heart disease, and an increasing rate of bone loss. Estrogen is available as an oral drug, a transdermal patch, or as a gel or lotion. Transdermal estrogen is preferable as compared to oral, since it avoids the first-pass metabolism in the liver. Since release of the WHI findings, current treatment recommendations are for the lowest effective dose for the shortest period of time to treat postmenopausal symptoms.

Comparison: Three doses of a transdermal estradiol gel as compared to placebo for the treatment of vasomotor and vulvovaginal atrophy symptoms in postmenopausal women.

Inclusion Criteria:

• Postmenopausal women
• serum estradiol level less than or equal to 20 pg per mL
• serum FSH greater than 40 mIU per mL

Exclusion Criteria:

• Pathological cancer findings on screening
• abnormal endometrium
• serious hepatic, renal or cardiac disease