Hot Flashes
Conditions
Keywords
Menopause
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.
Interventions
DRUGMenostar (estradiol transdermal delivery system)
Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
DRUGPlacebo
Placebo patch
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Evidence of postmenopausal status
Exclusion criteria
* Contraindication to estrogen therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change in frequency of hot flushes | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in vaginal pH | 12 weeks |
| Changes in vaginal maturation index | 12 weeks |
| Occurrence of urogenital symptoms | 12 weeks |
| Change in intensity of hot flushes | 12 weeks |
| Bleeding profile | 12 weeks |
| Safety | 12 weeks |
| Change in MENQOL (menopausal quality of life questionaire) | 12 weeks |
Outcome results
None listed