Vasomotor SymptomsPhase 4NCT00472004
Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women
A Phase 4 study testing 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle) and Tibolone (Livial) in people with Vasomotor Symptoms, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Mexico.
Trial summary
This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone). Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms
- What is being tested?
- 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle) and Tibolone (Livial)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2006to Dec 2009
- Phase
- Phase 4
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy postmenopausal women
- Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12 consecutive months prior to screening and without any other kind of gynecological bleeding during this same period
- At least 1 year of natural occurring amenorrhea
Who cannot join
- Known or suspected estrogen-dependent neoplasia
- Endometrial hyperplasia
- Any malignancy with the exception of a history of basal cell carcinoma of the skin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Open Label Study To Compare The Efficacy, Safety And Tolerability Of 17-B Estradiol/Trimegestone CC 1 Mg (Totelle) And Tibolone (Livial) In Postmenopausal Women.
This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).
- Conditions
- Vasomotor Symptoms
- Being tested
- 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle), Tibolone (Livial)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)Drug
Also called Totelle
17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration
Tibolone (Livial)Drug
Also called Livial
Tibolone 2.5 mg 1 daily, 1 year duration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 17B Estradiol (1mg) / (0.125 mg) Trimegestone (TMG) Continuous combined, 1 Daily, 1 year duration Receives: Drug: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle) |
| 2 | Active comparator | Tibolone 2.5 mg 1 daily, 1 year duration Receives: Drug: Tibolone (Livial) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased of Vasomotor Symptoms [from baseline to six and twelve months]
Measured: 1 year
Secondary outcomes (4)
Changes in Body Weight (from baseline to six and twelve months)
Measured: 1 year
Quality of Life (from baseline to six and twelve months)
Measured: 1 year
Treatment Adherence (from baseline to six and twelve months)
Measured: 1 year
Breast Tenderness (from baseline to six and twelve months)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study startFeb 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor SymptomsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472004
- Sponsor's protocol ID
- 0753T-101800
- Other IDs
- B2481004
- Status last verified
- Oct 2010
- First submitted
- 8 May 2007
- Last updated
- 29 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open Label Study To Compare The Efficacy, Safety And Tolerability Of 17-B Estradiol/Trimegestone CC 1 Mg (Totelle) And Tibolone (Livial) In Postmenopausal Women.
- ClinicalTrials.gov ID
- NCT00472004
- Acronym / sponsor ID
- 0753T-101800
- Conditions
- Vasomotor Symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 May 2007 (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.
This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)17B Estradiol (1mg) / (0.125 mg) Trimegestone (TMG) Continuous combined, 1 Daily, 1 year duration |
| 2 | Active comparator | Drug: Tibolone (Livial)Tibolone 2.5 mg 1 daily, 1 year duration |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Generally healthy postmenopausal women
- Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12 consecutive months prior to screening and without any other kind of gynecological bleeding during this same period
- At least 1 year of natural occurring amenorrhea
Key exclusion criteria (3 listed)
- Known or suspected estrogen-dependent neoplasia
- Endometrial hyperplasia
- Any malignancy with the exception of a history of basal cell carcinoma of the skin
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 |
|---|---|---|
| 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)Also: Totelle17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration | Drug | 1 |
| Tibolone (Livial)Also: LivialTibolone 2.5 mg 1 daily, 1 year duration | Drug | 2 |
Primary outcome
Decreased of Vasomotor Symptoms [from baseline to six and twelve months]
Time frame: 1 year
4 secondary outcomes
Changes in Body Weight (from baseline to six and twelve months)
Time frame: 1 year
Quality of Life (from baseline to six and twelve months)
Time frame: 1 year
Treatment Adherence (from baseline to six and twelve months)
Time frame: 1 year
Breast Tenderness (from baseline to six and twelve months)
Time frame: 1 year
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 29 Oct 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle) and Tibolone (Livial) in people with Vasomotor Symptoms, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Mexico.
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 3 inclusion and 3 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 29 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Decreased of Vasomotor Symptoms [from baseline to six and twelve months] (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2010.