Status:
COMPLETED
Tibolone Endometrium Study (Study 32972)(P06470)
Lead Sponsor:
Organon and Co
Conditions:
Postmenopausal Women
Eligibility:
FEMALE
45-65 years
Phase:
PHASE3
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 tibolo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2005
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00745108
Start Date
October 1 2001
End Date
July 21 2005
Last Update
February 3 2022
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