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Tibolone Endometrium Study (Study 32972)(P06470)

NCT00745108 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-02-03

No results posted yet for this study

Summary

Tibolone has been registered for the treatment of climacteric symptoms and for the prevention of postmenopausal osteoporosis. This is a 2-year study to further confirm the endometrial safety of tibolone in comparison with CE/MPA.

Conditions

  • Postmenopausal Women

Interventions

DRUG

tibolone

oral 1.25 mg tablet, once daily, for 2 years

DRUG

Tibolone 2.5 mg

oral 2.5 mg tablet, once daily, for 2 years

DRUG

CE/MPA

oral, 0.625 mg tablet conjugated equine estrogen and 2.5 mg medroxyprogesterone acetate tablet placed together in a single capsule, once daily, for 2 years

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-10-01
Primary Completion
2005-07-21
Completion
2005-07-21

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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 NCT00745108 on ClinicalTrials.gov