Tibolone Endometrium Study (Study 32972)(P06470)

A Multinational, Multicenter, Randomized, Double-blind, Parallel Group, Active Controlled, Comparative Trial, to Assess the Endometrial Histological Profile Following Treatment With Tibolone (Org OD14) Versus Conjugated Estrogen (CE) Plus Medroxyprogesterone Acetate (MPA) in Postmenopausal Women

Tibolone has been registered for the treatment of climacteric symptoms and for the prevention of postmenopausal osteoporosis. This is a 2-year study to further confirm the endometrial safety of tibolone in comparison with CE/MPA.

Inclusion Criteria:

• Healthy postmenopausal women, 45 to 65 years of age with an intact uterus. Women must have been postmenopausal for less than 15 years, have an atrophic or inactive endometrium, and a body mass index of 18 - 32 kg/ m2 (inclusive).

Exclusion Criteria:

• Final diagnosis of the endometrial biopsy as 'no tissue' or 'tissue insufficient for diagnosis'.
• Double layer endometrial thickness > 6 mm as assessed by transvaginal ultrasonography (TVUS).
• Any previous or current unopposed estrogen administration or tamoxifen citrate.
• Any unexplained vaginal bleeding following the menopause.
• Women with abnormal Pap smear test results (PAP IIb and higher)
• Previous use of raloxifene hydrochloride for longer than one month.