Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- Mean change from baseline in number of daily moderate to severe hot flushes.
- Mean change from baseline in daily hot flush severity.
- Mean change from baseline in vulvovaginal atrophy symptoms.
- Percent change from baseline in daily moderate to severe hot flush rates over time.
- Percent change from baseline in hot flush severity over time.
- Proportion of subjects with fifty to one hundred percent reductions in daily moderate to severe hot flushes.
- Proportion of subjects with fifty to one hundred percent reductions in hot flush severity
- Mean change from baseline in subject vaginal health self assessment over time.
- Mean change from baseline in physician assessment of vaginal atrophy.
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||April 2005|
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.