Status:
COMPLETED
Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms
Lead Sponsor:
BioSante Pharmaceuticals
Conditions:
Hot Flashes
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 e...
Eligibility Criteria
Inclusion
- Postmenopausal women
- serum estradiol level less than or equal to 20 pg per mL
- serum FSH greater than 40 mIU per mL
Exclusion
- Pathological cancer findings on screening
- abnormal endometrium
- serious hepatic, renal or cardiac disease
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
431 Patients enrolled
Trial Details
Trial ID
NCT00391417
Start Date
September 1 2003
End Date
April 1 2005
Last Update
October 24 2006
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