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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
165
Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
Placebo patch
Relative change in frequency of hot flushes
Time frame: 12 weeks
Change in intensity of hot flushes
Time frame: 12 weeks
Changes in vaginal pH
Time frame: 12 weeks
Changes in vaginal maturation index
Time frame: 12 weeks
Occurrence of urogenital symptoms
Time frame: 12 weeks
Change in MENQOL (menopausal quality of life questionaire)
Time frame: 12 weeks
Bleeding profile
Time frame: 12 weeks
Safety
Time frame: 12 weeks
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