Status:
COMPLETED
Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Menopause
Eligibility:
FEMALE
45-65 years
Phase:
PHASE4
Brief Summary
This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone in comparison with tibolone on the breast metabolic markers, in particular the total insulin-like growth fac...
Eligibility Criteria
Inclusion
- Natural or surgical postmenopausal amenorrhea since ≥ 12 months,
- non hysterectomized women, complaining of at least 14 hot flushes per week
Exclusion
- Known, suspected or history of breast cancer or hormone-dependent neoplasia,
- undiagnosed genital bleeding,
- venous or arterial history or presence of thromboembolism,
- cerebrovascular disease
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00145522
Start Date
November 1 2005
End Date
March 1 2009
Last Update
April 1 2009
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 8
Ancona, Italy
2
Site 15
Cagliari, Italy
3
Site 4
Catania, Italy
4
Site 9
Florence, Italy