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Effects of Tibolone Treatment on the Endometrium

This study has been completed.
Information provided by:
Erasmus Medical Center Identifier:
First received: February 17, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted

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
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Tibolone Treatment on the Endometrium

Resource links provided by NLM:

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • 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


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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:

  1. 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)).
  2. Double-layer endometrium thickness > 4 mm as assessed by transvaginal ultrasound, immediately before endometrial biopsy.
  3. History or presence of any malignancy, except successfully treated non-melanoma skin cancers.
  4. Any unexpected vaginal bleeding following the menopause.
  5. Liver disease, except cholecystectomy.
  6. Abnormal cervical Pap smear test result, or abnormal mammography result obtained within one year prior to the start of the trial
  7. Deep vein thrombosis, thrombophlebitis, thromboembolic disease, or suspicions of having hereditary predisposition for developing venous thromboembolic disease.
  8. 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).
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Please refer to this study by its identifier: NCT00294463

Erasmus MC
Rotterdam, Netherlands, 3000 CA
Sponsors and Collaborators
Erasmus Medical Center
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

Publications automatically indexed to this study by Identifier (NCT Number): 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

Keywords provided by Erasmus Medical Center:
Gene Expression Profiling
Histology, Comparative
Hormone Replacement Therapy

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Medroxyprogesterone Acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Androgen Antagonists
Hormone Antagonists
Antihypertensive Agents
Estrogen Receptor Modulators processed this record on June 22, 2017