Tibolone Endometrium Study (Study 32972)(P06470)
THEBES
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
2 other identifiers
interventional
32
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2001
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2005
CompletedFirst Submitted
Initial submission to the registry
September 2, 2008
CompletedFirst Posted
Study publicly available on registry
September 3, 2008
CompletedFebruary 3, 2022
February 1, 2022
3.8 years
September 2, 2008
February 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Endometrial biopsy and histological examination
At 1 year and 2 year.
Secondary Outcomes (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
Study Arms (3)
Tibolone 1.25 mg
EXPERIMENTALTibolone 2.5 mg
EXPERIMENTALCE/MPA
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
Archer DF, Hendrix S, Ferenczy A, Felix J, Gallagher JC, Rymer J, Skouby SO, den Hollander W, Stathopoulos V, Helmond FA; THEBES Study Group. Tibolone histology of the endometrium and breast endpoints study: design of the trial and endometrial histology at baseline in postmenopausal women. Fertil Steril. 2007 Oct;88(4):866-78. doi: 10.1016/j.fertnstert.2006.12.052. Epub 2007 Jun 4.
PMID: 17548089BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2008
First Posted
September 3, 2008
Study Start
October 1, 2001
Primary Completion
July 21, 2005
Study Completion
July 21, 2005
Last Updated
February 3, 2022
Record last verified: 2022-02