Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women
- Registration Number
- NCT00145522
- Lead Sponsor
- Solvay Pharmaceuticals
- 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 factor-1 (IGF-1), in postmenopausal women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 135
Inclusion Criteria
- Natural or surgical postmenopausal amenorrhea since ≥ 12 months,
- non hysterectomized women, complaining of at least 14 hot flushes per week
Exclusion Criteria
- Known, suspected or history of breast cancer or hormone-dependent neoplasia,
- undiagnosed genital bleeding,
- venous or arterial history or presence of thromboembolism,
- cerebrovascular disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 17ß-Estradiol/Dydrogesterone - 2 Tibolone -
- Primary Outcome Measures
Name Time Method IGF1 values after 12 cycles of 28 days 1 year
- Secondary Outcome Measures
Name Time Method after 12 cycles of 28 days: other breast metabolic markers [IGFBP 1 and 3, SHBG, free estradiol, fasting insulin], breast tenderness and breast density, cardiovascular metabolic markers, menopausal symptoms and bleeding pattern 1 year
Trial Locations
- Locations (11)
Site 8
🇮🇹Ancona, Italy
Site 9
🇮🇹Firenze, Italy
Sit 14
🇮🇹Modena, Italy
Site 6
🇮🇹Roma, Italy
Site 2
🇮🇹Torino, Italy
Site 7
🇮🇹Udine, Italy
Site 15
🇮🇹Cagliari, Italy
Site 4
🇮🇹Catania, Italy
Site 10
🇮🇹Milano, Italy
Site 11
🇮🇹Milano, Italy
Site 1
🇮🇹Torino, Italy