Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch
Phase 3
Completed
- Conditions
- Hot Flashes
- Interventions
- Registration Number
- NCT00185237
- Lead Sponsor
- Bayer
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 165
Inclusion Criteria
- Evidence of postmenopausal status
Exclusion Criteria
- Contraindication to estrogen therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Placebo - Arm 1 Menostar (estradiol transdermal delivery system) -
- Primary Outcome Measures
Name Time Method Relative change in frequency of hot flushes 12 weeks
- Secondary Outcome Measures
Name Time Method Changes in vaginal pH 12 weeks Changes in vaginal maturation index 12 weeks Safety 12 weeks Bleeding profile 12 weeks Change in intensity of hot flushes 12 weeks Occurrence of urogenital symptoms 12 weeks Change in MENQOL (menopausal quality of life questionaire) 12 weeks