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

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioSante Pharmaceuticals
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

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