Tibolone Endometrium Study (Study 32972)(P06470) (THEBES)

February 2, 2022 updated by: Organon and Co

A Multinational, Multicenter, Randomized, Double-blind, Parallel Group, Active Controlled, Comparative Trial, to Assess the Endometrial Histological Profile Following Treatment With Tibolone (Org OD14) Versus Conjugated Estrogen (CE) Plus Medroxyprogesterone Acetate (MPA) in Postmenopausal Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy postmenopausal women, 45 to 65 years of age with an intact uterus. Women must have been postmenopausal for less than 15 years, have an atrophic or inactive endometrium, and a body mass index of 18 - 32 kg/ m2 (inclusive).

Exclusion Criteria:

  • Final diagnosis of the endometrial biopsy as 'no tissue' or 'tissue insufficient for diagnosis'.
  • Double layer endometrial thickness > 6 mm as assessed by transvaginal ultrasonography (TVUS).
  • Any previous or current unopposed estrogen administration or tamoxifen citrate.
  • Any unexplained vaginal bleeding following the menopause.
  • Women with abnormal Pap smear test results (PAP IIb and higher)
  • Previous use of raloxifene hydrochloride for longer than one month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tibolone 1.25 mg
Drug: tibolone
oral 1.25 mg tablet, once daily, for 2 years
Experimental: Tibolone 2.5 mg
Drug: Tibolone 2.5 mg
oral 2.5 mg tablet, once daily, for 2 years
Other Names:
  • Livial
Active Comparator: CE/MPA
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
Other Names:
  • Provera
  • Premarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endometrial biopsy and histological examination
Time Frame: At 1 year and 2 year.
At 1 year and 2 year.

Secondary Outcome Measures

Outcome Measure
Time Frame
Double-layer endometrial thickness by transvaginal ultrasonography (TVUS), vaginal bleeding from a Bleeding Episode Log.
Time Frame: TVUS: at 1 year and 2 year; Vaginal bleeding: daily recording
TVUS: at 1 year and 2 year; Vaginal bleeding: daily recording

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2001

Primary Completion (Actual)

July 21, 2005

Study Completion (Actual)

July 21, 2005

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P06470
  • 32972

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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