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Effects of Tibolone Treatment on the Endometrium
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
Details
| Lead sponsor | Erasmus Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 35 |
| Start date | 2003-02 |
| Completion | 2005-03 |
Conditions
- Postmenopause
- Osteoporosis
Interventions
- Tibolone
- Estradiol
- Estradiol + Medroxy Progesterone Acetate
Primary outcomes
- Histologic evaluation of the endometrium at the end of treatment
- Biochemical evaluation (hormone measurements) of uterine tissue at the end of treatment
- Biochemical evaluation of sera, obtained just prior to treatment and at surgery
- Molecular assessment of gene expression
Countries
Netherlands