Treatment of Hot Flushes in Asian Women With Ultra-Low Dose Estradiol Patch
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hot Flashes; Menopause
Intervention: Menostar┬« (estradiol transdermal delivery system) (Drug); Placebo (Drug)
Phase: Phase 3
Sponsored by: Bayer
Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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.
Official title: 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.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Relative change in frequency of hot flushes
Change in intensity of hot flushes
Changes in vaginal pH
Changes in vaginal maturation index
Occurrence of urogenital symptoms
Change in MENQOL (menopausal quality of life questionaire)
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.
Minimum age: 45 Years.
Maximum age: 65 Years.
- Evidence of postmenopausal status
- Contraindication to estrogen therapy
Locations and Contacts
Click here and search for drug information provided by the FDA
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product
Click here to find results for studies related to marketed products
Starting date: July 2005
Ending date: November 2006
Last updated: April 29, 2008