Postmenopausal Women
Conditions
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.
Interventions
DRUGtibolone
oral 1.25 mg tablet, once daily, for 2 years
DRUGTibolone 2.5 mg
oral 2.5 mg tablet, once daily, for 2 years
DRUGCE/MPA
oral, 0.625 mg tablet conjugated equine estrogen and 2.5 mg medroxyprogesterone acetate tablet placed together in a single capsule, once daily, for 2 years
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endometrial biopsy and histological examination | At 1 year and 2 year. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed