Status:
COMPLETED
Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Hot Flushes, Menopause, Postmenopause
Eligibility:
FEMALE
45-65 years
Phase:
PHASE2
Brief Summary
This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination co...
Eligibility Criteria
Inclusion
- Be able to communicate with the Investigator and study staff and be able to complete the required study procedures,
- Be a female of any race between the ages of 45-65 years, in generally good health,
- Be either naturally or surgically postmenopausal (with or without a uterus)
Exclusion
- Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
- History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
1251 Patients enrolled
Trial Details
Trial ID
NCT00160342
Start Date
June 1 2005
End Date
September 1 2007
Last Update
August 15 2008
Active Locations (125)
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1
Site 37
Montgomery, Alabama, United States
2
Site 69
Montgomery, Alabama, United States
3
Site 44
Tucson, Arizona, United States
4
Site 6
Jonesboro, Arkansas, United States