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Effects of Tibolone Treatment on the Endometrium

NCT00294463 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2006-02-22

No results posted yet for this study

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

Conditions

Interventions

DRUG

Tibolone

DRUG

Estradiol

DRUG

Estradiol + Medroxy Progesterone Acetate

Sponsors & Collaborators

Principal Investigators

  • Curt W Burger, MD, PhD · Erasmus MC, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands

  • Leen J Blok, PhD · Erasmus MC, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-02-28
Completion
2005-03-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00294463 on ClinicalTrials.gov