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Effects of Tibolone Treatment on the Endometrium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00294463
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : February 22, 2006
Sponsor:
Collaborator:
Organon
Information provided by:
Erasmus Medical Center

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 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 or disease Intervention/treatment Phase
Postmenopause Osteoporosis Drug: Tibolone Drug: Estradiol Drug: Estradiol + Medroxy Progesterone Acetate Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Tibolone Treatment on the Endometrium
Study Start Date : February 2003
Estimated Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources




Primary Outcome Measures :
  1. Histologic evaluation of the endometrium at the end of treatment
  2. Biochemical evaluation (hormone measurements) of uterine tissue at the end of treatment
  3. Biochemical evaluation of sera, obtained just prior to treatment and at surgery
  4. Molecular assessment of gene expression


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294463


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

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
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: February 22, 2006
Last Verified: February 2006

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
Metabolic Diseases
Estradiol
Polyestradiol phosphate
Progesterone
Tibolone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Medroxyprogesterone
Medroxyprogesterone Acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins
Androgen Antagonists
Hormone Antagonists
Antihypertensive Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Modulators
Anabolic Agents
Contraceptives, Oral, Synthetic