Hot Flashes Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Active, not recruiting |
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