Effects of Tibolone Treatment on the Endometrium
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Purpose
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 for the treatment of symptoms associated with menopause and osteoporosis. The current study compares endometrial histology, biochemistry (hormone levels) and gene-expression profiles after short-term (21-days) treatment with tibolone, to the findings after treatment with estradiol-only (E2) and E2+Medroxyprogesterone Acetate (MPA) in healthy postmenopausal women undergoing hysterectomy for endometrial prolaps.
Since short-term tibolone use results in increased spotting and bleeding but long-term treatment with tibolone has been shown to lead to an atrophic endometrium our hypothesis is that tibolone first displays a more estrogenic mode of action, which over time, is counterbalanced by tibolone's progestagenic properties
| Condition | Intervention | Phase |
|---|---|---|
|
Postmenopause Osteoporosis |
Drug: Tibolone Drug: Estradiol Drug: Estradiol + Medroxy Progesterone Acetate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Tibolone Treatment on the Endometrium |
- Histologic evaluation of the endometrium at the end of treatment
- Biochemical evaluation (hormone measurements) of uterine tissue at the end of treatment
- Biochemical evaluation of sera, obtained just prior to treatment and at surgery
- Molecular assessment of gene expression
| Estimated Enrollment: | 35 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | March 2005 |
Show Detailed Description Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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 Criteria:
- 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).
Contacts and Locations| Netherlands | |
| Erasmus MC | |
| Rotterdam, Netherlands, 3000 CA | |
| Principal Investigator: | Curt W Burger, MD, PhD | Erasmus MC, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands |
| Principal Investigator: | Leen J Blok, PhD | Erasmus MC, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands |
More Information
No publications provided by Erasmus Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00294463 History of Changes |
| Other Study ID Numbers: | MEC 217.640/2002/220 |
| Study First Received: | February 17, 2006 |
| Last Updated: | February 17, 2006 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Erasmus Medical Center:
|
postmenopause endometrium Gene Expression Profiling |
Histology, Comparative Hormone Replacement Therapy Hormones |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Estradiol Polyestradiol phosphate Progesterone Tibolone Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Medroxyprogesterone Medroxyprogesterone Acetate Estrogens Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Male Antineoplastic Agents, Hormonal Antineoplastic Agents Progestins Androgen Antagonists Hormone Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013