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Completed

NCT Number: NCT00745108

Tibolone Endometrium Study (Study 32972)(P06470)

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.

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Key information

Conditions

Postmenopausal Women

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tibolone

Drug

oral 1.25 mg tablet, once daily, for 2 years

Tibolone 2.5 mg

Drug

oral 2.5 mg tablet, once daily, for 2 years

Other names: Livial

CE/MPA

Drug

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: Premarin, Provera

Primary outcomes

  1. Endometrial biopsy and histological examination

    Time frame: At 1 year and 2 year.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Acronym: THEBES

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Sep 3, 2008
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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