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
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
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
Secondary outcome: Change in intensity of hot flushesChanges in vaginal pH Changes in vaginal maturation index Occurrence of urogenital symptoms Change in MENQOL (menopausal quality of life questionaire) Bleeding profile Safety
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.
Eligibility
Minimum age: 45 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Evidence of postmenopausal status
Exclusion Criteria:
- Contraindication to estrogen therapy
Locations and Contacts
Additional Information
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Starting date: July 2005
Ending date: November 2006
Last updated: April 29, 2008
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