Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
BioSante Pharmaceuticals |
---|---|
Information provided by: | BioSante Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00391417 |
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.
Condition | Intervention | Phase |
---|---|---|
Hot Flashes |
Drug: estradiol gel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 431 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | EST005 |
Study First Received: | October 20, 2006 |
Last Updated: | October 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00391417 History of Changes |
Health Authority: | United States: Food and Drug Administration |
hot flush hot flash estrogen vaginal atrophy |
Estrogens Contraceptive Agents Benzoates Hormone Antagonists Estradiol valerate Contraceptive Agents, Female Hot Flashes Hormones, Hormone Substitutes, and Hormone Antagonists |
Estradiol 17 beta-cypionate Hormones Estradiol Signs and Symptoms Estradiol 3-benzoate Flushing Atrophy Polyestradiol phosphate |
Estrogens Contraceptive Agents Estradiol valerate Physiological Effects of Drugs Contraceptive Agents, Female Hot Flashes Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents |
Estradiol 17 beta-cypionate Hormones Estradiol Pharmacologic Actions Signs and Symptoms Therapeutic Uses Estradiol 3-benzoate Polyestradiol phosphate |