Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms
Information source: BioSante Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hot Flashes
Intervention: estradiol gel (Drug)
Phase: Phase 3
Sponsored by: BioSante Pharmaceuticals
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.
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.
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.
Minimum age: 18 Years.
Maximum age: N/A.
- Postmenopausal women
- serum estradiol level less than or equal to 20 pg per mL
- serum FSH greater than 40 mIU per mL
- Pathological cancer findings on screening
- abnormal endometrium
- serious hepatic, renal or cardiac disease
Locations and Contacts
Starting date: September 2003
Ending date: April 2005
Last updated: October 20, 2006