Trial Condition(s):
Hot Flashes
Treatment of hot flushes in Asian women with ultra-low dose estradiol patch
Bayer Identifier:
91441
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Evidence of postmenopausal status
Exclusion Criteria
- Contraindication to estrogen therapy
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
|---|
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Relative change in frequency of hot flushesTimeframe: 12 weeks
Secondary Outcome
- Change in intensity of hot flushesTimeframe: 12 weeks
- Changes in vaginal pHTimeframe: 12 weeks
- Changes in vaginal maturation indexTimeframe: 12 weeks
- Occurrence of urogenital symptomsTimeframe: 12 weeks
- Change in MENQOL (menopausal quality of life questionaire)Timeframe: 12 weeks
- Bleeding profileTimeframe: 12 weeks
- SafetyTimeframe: 12 weeks
Additional Information
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