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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular pathways does 17β-estradiol/dydrogesterone modulate in breast tissue compared to tibolone in postmenopausal women?
How does the cardiovascular metabolic profile of combined HRT compare to tibolone in NCT00145522 postmenopausal patients?
Which biomarkers correlate with IGF-1 suppression in response to 17β-estradiol/dydrogesterone versus tibolone in menopausal women?
What adverse event profiles distinguish 17β-estradiol/dydrogesterone from tibolone in long-term HRT for postmenopausal women?
How do combination therapies like 17β-estradiol/dydrogesterone compare to SERMs or progestin-only regimens in managing menopausal metabolic risks?
Trial Locations
- Locations (11)
Site 8
🇮🇹Ancona, Italy
Site 15
🇮🇹Cagliari, Italy
Site 4
🇮🇹Catania, Italy
Site 9
🇮🇹Firenze, Italy
Site 10
🇮🇹Milano, Italy
Site 11
🇮🇹Milano, Italy
Sit 14
🇮🇹Modena, Italy
Site 6
🇮🇹Roma, Italy
Site 1
🇮🇹Torino, Italy
Site 2
🇮🇹Torino, Italy
Scroll for more (1 remaining)Site 8🇮🇹Ancona, Italy