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Effects of Tibolone Treatment on the Endometrium

This study has been completed.
Sponsor:
Collaborator:
Organon
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00294463
First received: February 17, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  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

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

  Eligibility

Genders 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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
Bone Diseases, Metabolic
Musculoskeletal Diseases
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Medroxyprogesterone
Medroxyprogesterone Acetate
Polyestradiol phosphate
Progesterone
Tibolone
Anabolic Agents
Androgen Antagonists
Antihypertensive Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Estrogen Receptor Modulators
Estrogens
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014