Tibolone Endometrium Study (Study 32972)(P06470)
Phase 3
Completed
- Conditions
- Postmenopausal Women
- Interventions
- Registration Number
- NCT00745108
- Lead Sponsor
- Organon and Co
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CE/MPA CE/MPA - Tibolone 2.5 mg Tibolone 2.5 mg - Tibolone 1.25 mg tibolone -
- Primary Outcome Measures
Name Time Method Endometrial biopsy and histological examination At 1 year and 2 year.
- Secondary Outcome Measures
Name Time Method Double-layer endometrial thickness by transvaginal ultrasonography (TVUS), vaginal bleeding from a Bleeding Episode Log. TVUS: at 1 year and 2 year; Vaginal bleeding: daily recording