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

Tracking Information
First Received Date ^ICMJE	October 20, 2006
Last Updated Date	October 20, 2006
Start Date ^ICMJE	September 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: October 20, 2006)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: October 20, 2006)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms
Official Title ^ICMJE	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
Brief Summary	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	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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Hot Flashes
Intervention ^ICMJE	Drug: estradiol gel
Study Arms / Comparison Groups
Publications *	Simon JA, Bouchard C, Waldbaum A, Utian W, Zborowski J, Snabes MC. Low dose of transdermal estradiol gel for treatment of symptomatic postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007 Mar;109(3):588-96.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	431
Completion Date	April 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00391417
Responsible Party
Study ID Numbers ^ICMJE	EST005
Study Sponsor ^ICMJE	BioSante Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	BioSante Pharmaceuticals
Verification Date	October 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP