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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hot Flashes

Intervention / Treatment
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* Drug: estradiol gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: estradiol gel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hot flush, hot flash, estrogen, vaginal atrophy