Status:
COMPLETED
Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
Lead Sponsor:
Bayer
Conditions:
Vasomotor Symptoms
Hot Flashes
Eligibility:
FEMALE
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.
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
- \- Postmenopausal women \>40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week
Exclusion
- The usual exclusion criteria for hormone therapy apply
- Intake of medications other than hormones affecting hot flushes
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
735 Patients enrolled
Trial Details
Trial ID
NCT00446199
Start Date
March 1 2007
End Date
November 1 2008
Last Update
May 6 2015
Active Locations (76)
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1
Mobile, Alabama, United States, 36608
2
Chandler, Arizona, United States, 85225
3
Phoenix, Arizona, United States, 85031
4
Tucson, Arizona, United States, 85712