Overview

Effects of Tibolone Treatment on the Endometrium

Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
Participant gender:
Summary
Tibolone, a tissue-selective compound with a combination of estrogenic, progestogenic and androgenic properties, is used as an alternative for estrogen or estrogen plus progesterone hormone therapy for the treatment of symptoms associated with menopause and osteoporosis. The current study compares endometrial histology, biochemistry (hormone levels) and gene-expression profiles after short-term (21-days) treatment with tibolone, to the findings after treatment with estradiol-only (E2) and E2+Medroxyprogesterone Acetate (MPA) in healthy postmenopausal women undergoing hysterectomy for endometrial prolaps. Since short-term tibolone use results in increased spotting and bleeding but long-term treatment with tibolone has been shown to lead to an atrophic endometrium our hypothesis is that tibolone first displays a more estrogenic mode of action, which over time, is counterbalanced by tibolone's progestagenic properties
Phase:
Phase 4
Details
Lead Sponsor:
Erasmus Medical Center
Collaborator:
Organon
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Medroxyprogesterone
Medroxyprogesterone Acetate
Polyestradiol phosphate
Progesterone
Tibolone