Status:
COMPLETED
Effects of Tibolone Treatment on the Endometrium
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Organon
Conditions:
Postmenopause
Osteoporosis
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
Tibolone, a tissue-selective compound with a combination of estrogenic, progestogenic and androgenic properties, is used as an alternative for estrogen or estrogen plus progesterone hormone therapy fo...
Detailed Description
Effects of estrogen deficiency in women are climacteric symptoms and bone loss, which can efficiently be treated by substituting with estrogens (1). Unopposed estrogen treatment, however, increases th...
Eligibility Criteria
Inclusion
- Healthy postmenopausal women with a uterus. "Postmenopausal'' was defined as amenorrhoeic for at least one year prior to screening, or amenorrhoeic for at least six months prior to screening with a serum E2 concentration of \< 20 pg/ml and a serum FSH concentration of \> 40 IU/L at screening. If the patient used any kind of steroid hormone therapy prior to the study, a washout period of 6 months (for intra-uterine progesterone and oral estrogen+progestagen combination therapy) or 12 months (for progesterone implants or injections and injected estrogen+progestagen combination therapy) was applied.
Exclusion
- Histological diagnosis by a local pathologist of an endometrial biopsy (with the Pipelle suction curette) taken before treatment, as proliferative, secretory or menstrual type endometrium, endometrial metaplasia, endometrial or endocervical polyp(s), endometrial hyperplasia, cancer or any other histological abnormality (leiomyoma(ta), stromal nodules or mesenchymal or (endo)cervical neoplasia(s)).
- Double-layer endometrium thickness \> 4 mm as assessed by transvaginal ultrasound, immediately before endometrial biopsy.
- History or presence of any malignancy, except successfully treated non-melanoma skin cancers.
- Any unexpected vaginal bleeding following the menopause.
- Liver disease, except cholecystectomy.
- Abnormal cervical Pap smear test result, or abnormal mammography result obtained within one year prior to the start of the trial
- Deep vein thrombosis, thrombophlebitis, thromboembolic disease, or suspicions of having hereditary predisposition for developing venous thromboembolic disease.
- Use of one or more of the following drugs within the last two months: hepatic microsomal enzyme-inducing anticonvulsant drugs known to affect or interfere with the pharmacokinetics of steroids (e.g. hydantoins, barbiturates such as Phenobarbital (alone or in combinations, such as Bellergal) rifampicin, griseofulvin, primidone or carbamazepine).
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00294463
Start Date
February 1 2003
End Date
March 1 2005
Last Update
February 22 2006
Active Locations (1)
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1
Erasmus MC
Rotterdam, Netherlands, 3000 CA