NCT00185237

Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch

A Multicenter, Double-blind, Randomized, Placebo Controlled Study on the Effect of Ultra-low Dose Transdermal Estradiol (Menostar®) on the Incidence and Severity of Hot Flushes, Other Menopausal Symptoms and on Well-being in Postmenopausal Asian Women Over 12 Weeks.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.

Detailed description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Conditions

• Hot Flashes

Interventions

Type	Name	Description
DRUG	Menostar (estradiol transdermal delivery system)	Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
DRUG	Placebo	Placebo patch

Timeline

• Start date: 2005-07-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2005-09-16
• Last updated: 2014-12-23