Tibolone Endometrium Study (Study 32972)(P06470) (THEBES)

Organon

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Women

Treatments: Drug: Tibolone 2.5 mg; Drug: CE/MPA; Drug: tibolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00745108

32972

P06470

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 3 patient groups

Tibolone 1.25 mg

Experimental group

Treatment:

Drug: tibolone

Tibolone 2.5 mg

Experimental group

Treatment:

Drug: Tibolone 2.5 mg

CE/MPA

Active Comparator group

Treatment:

Drug: CE/MPA