Status:
COMPLETED
Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes
Lead Sponsor:
Bayer
Conditions:
Hot Flashes
Eligibility:
FEMALE
40+ years
Phase:
PHASE4
Brief Summary
To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in po...
Detailed Description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Eligibility Criteria
Inclusion
- Menopause
- Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days)
Exclusion
- Hormonal treatment
- Contraindication to estrogen/progestogen therapy
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT00206622
Start Date
December 1 2004
End Date
February 1 2006
Last Update
May 29 2009
Active Locations (45)
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1
Huntsville, Alabama, United States, 35801
2
Chandler, Arizona, United States, 85225
3
Phoenix, Arizona, United States, 85031
4
Tucson, Arizona, United States, 85712