Clincosm LogoSign in Get a demo

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

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00745108
Collaborator
(none)
32
Enrollment
3
Arms
45.6
Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official 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
Actual Study Start Date :
Oct 1, 2001
Actual Primary Completion Date :
Jul 21, 2005
Actual Study Completion Date :
Jul 21, 2005

Arms and Interventions

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:
  • Premarin
  • Provera

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Endometrial biopsy and histological examination [At 1 year and 2 year.]

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00745108
    Other Study ID Numbers:
    • P06470
    • 32972
    First Posted:
    Sep 3, 2008
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Tibolone

    Study Results

    No Results Posted as of Feb 3, 2022