Postmenopausal WomenPhase 3THEBESNCT00745108
Tibolone Endometrium Study (Study 32972)(P06470)
A Phase 3 study testing tibolone, Tibolone 2.5 mg and CE/MPA in people with Postmenopausal Women, run by Organon and Co.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- tibolone, Tibolone 2.5 mg and CE/MPA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2001to 21 Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
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
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
- Being tested
- tibolone, Tibolone 2.5 mg, CE/MPA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tiboloneDrug
oral 1.25 mg tablet, once daily, for 2 years
Tibolone 2.5 mgDrug
Also called Livial
oral 2.5 mg tablet, once daily, for 2 years
CE/MPADrug
Also called Premarin, Provera
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
| Study group | Role | What they receive |
|---|---|---|
| Tibolone 1.25 mg | Experimental | Not described Receives: Drug: tibolone |
| Tibolone 2.5 mg | Experimental | Not described Receives: Drug: Tibolone 2.5 mg |
| CE/MPA | Active comparator | Not described Receives: Drug: CE/MPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial biopsy and histological examination
Measured: At 1 year and 2 year.
Secondary outcomes (1)
Double-layer endometrial thickness by transvaginal ultrasonography (TVUS), vaginal bleeding from a Bleeding Episode Log.
Measured: TVUS: at 1 year and 2 year; Vaginal bleeding: daily recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study start1 Oct 2001
- Primary completion21 Jul 2005
- Study completion21 Jul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745108
- Sponsor's protocol ID
- P06470
- Other IDs
- 32972
- Acronym
- THEBES
- Status last verified
- Feb 2022
- First submitted
- 2 Sep 2008
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17548089
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00745108
- Acronym / sponsor ID
- THEBES / P06470
- Conditions
- Postmenopausal Women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2001 (actual)
- Primary completion
- 21 Jul 2005 (actual)
- Study completion
- 21 Jul 2005 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tibolone 1.25 mg | Experimental | Drug: tibolone |
| Tibolone 2.5 mg | Experimental | Drug: Tibolone 2.5 mg |
| CE/MPA | Active comparator | Drug: CE/MPA |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tiboloneoral 1.25 mg tablet, once daily, for 2 years | Drug | Tibolone 1.25 mg |
| Tibolone 2.5 mgAlso: Livialoral 2.5 mg tablet, once daily, for 2 years | Drug | Tibolone 2.5 mg |
| CE/MPAAlso: Premarin, Proveraoral, 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 | Drug | CE/MPA |
Primary outcome
Endometrial biopsy and histological examination
Time frame: At 1 year and 2 year.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Background: PubMed 17548089Archer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tibolone, Tibolone 2.5 mg and CE/MPA in people with Postmenopausal Women, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial biopsy and histological examination (time frame: At 1 year and 2 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00745108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.