Flow-mediated Dilation Evaluation of the Brachial ArteryNCT01679795
Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
A study testing Tibolone in people with Flow-mediated Dilation Evaluation of the Brachial Artery, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the vascular effects of tibolone on climateric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Flow-mediated Dilation Evaluation of the Brachial Artery
- What is being tested?
- Tibolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to Feb 2015
- Phase
- Interventional
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women without menstrual cycles whithin the last 12 months and FSH>30IU/L
- Healthy women
- Women that were not using drugs with potential vascular effect whithin the last 1 year
- Women that never used hormone replacement therapy
Who cannot join
- Smoking
- Blood Pressure > 160/90 mm Hg.
- Breast and or endometrial cancer
- History of acute myocardial infarction
- Diabetes
- Vaginal bleeding of any origin
- Hepatic disease
- thrombophlebitis or thromboembolic disorders
Trial locations and contacts
1 site in 1 country.
Brazil1 site
hospital das Clinicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130100
About this study
The aim of this study is to evaluate the vascular effects of tibolone on climateric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.
- Being tested
- Tibolone, Placebo
- Keywords
- hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; tibolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiboloneDrug
Also called Livial
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tibolone | Experimental | patientes will use tibolone 2,5mg/day during 30 days Receives: Drug: Tibolone |
| Placebo use | Placebo comparator | Patients will use placebo for 30 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery
Flow-mediated dilation will be measured by high resolution ultrasound
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flow-mediated Dilation Evaluation of the Brachial ArteryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selmo Geber, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679795
- Sponsor's protocol ID
- TDILA
- Status last verified
- Apr 2015
- First submitted
- 3 Sep 2012
- Last updated
- 3 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
- ClinicalTrials.gov ID
- NCT01679795
- Acronym / sponsor ID
- TDILA
- Keywords
- hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; tibolone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Sep 2012 (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.
The aim of this study is to evaluate the vascular effects of tibolone on climateric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tibolone | Experimental | Drug: Tibolonepatientes will use tibolone 2,5mg/day during 30 days |
| Placebo use | Placebo comparator | Drug: PlaceboPatients will use placebo for 30 days |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women without menstrual cycles whithin the last 12 months and FSH>30IU/L
- Healthy women
- Women that were not using drugs with potential vascular effect whithin the last 1 year
- Women that never used hormone replacement therapy
Key exclusion criteria (8 listed)
- Smoking
- Blood Pressure > 160/90 mm Hg.
- Breast and or endometrial cancer
- History of acute myocardial infarction
- Diabetes
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 |
|---|---|---|
| TiboloneAlso: Livial | Drug | Tibolone |
| Placebo | Drug | Placebo use |
Primary outcome
Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery
Time frame: 30 days
Flow-mediated dilation will be measured by high resolution ultrasound
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 Apr 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibolone in people with Flow-mediated Dilation Evaluation of the Brachial Artery, run by Federal University of Minas Gerais at 1 site in Brazil.
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 4 inclusion and 8 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 Apr 2015. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery (time frame: 30 days). 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 3 Apr 2015.