Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Dydrogesterone; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate; Tibolone

Criteria

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