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MenopauseTDILANCT01543399

Vascular Effect of Tibolone in the Brachial Artery

A study testing Tibolone in people with Menopause, run by Selmo Geber at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The interruption of the secretion of sex steroids occurring during menopause, causes a change in vascular pattern at various levels. As a result, several agencies have side effects that interfere with women's health. The use of hormone replacement therapy has contributed to the improvement in these effects. 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
Menopause
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
Mar 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 45 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women without menstrual cycles within the last 12 months and FSH > 30IU/L
  • Healthy women
  • Women that were not using drugs with potential vascular effect within 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

Other trials in Brazil

About this study

Official title: Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery

The interruption of the secretion of sex steroids occurring during menopause, causes a change in vascular pattern at various levels. As a result, several agencies have side effects that interfere with women's health. The use of hormone replacement therapy has contributed to the improvement in these effects. In previous studies the investigators showed the effect of sex steroids in premenopausal women in the conjugated equine estrogens, medroxyprogesterone acetate and tibolone in menopausal women, on the central retinal arteries. The aim of this study is to evaluate the effects of Tibolone in Flow-Mediated Dilatation of the brachial artery.

Read the detailed description

Menopause is a transitional phase of the biological evolution of women where there is loss of reproductive capacity. The phenomena are the most striking manifestations represented by vasomotor hot flushes and sweating, the consequent fall in estradiol production by the ovaries. The main landmark of the menopause is menopause, which is the last period governed by the ovaries, reflecting the depletion of the same follicle.

The main clinical manifestations of the climacteric are vascular, acting through mechanisms of action not fully understood. Several studies were published showing its effect on vasomotor tone and demonstrating the production of vasoactive substances by vascular cells induced by them.

The main objective of HRT (Hormone Replacement Therapy), is to improve the physical and psychological state of women who have climacteric disorders, leading to improved quality of life. The American College of Physicians, after careful review of available evidence, it is recommended that all postmenopausal women should be considered eligible to receive HRT and that the decision to treat or not should be individualized. Besides the knowledge of the pattern of endocrine patients climate, the investigators must subject it to full physical examination (pelvic) and exams before planning to start HRT. Complementary tests must be clinically oriented, respecting the resources available. There is no need to make routine use of doses of gonadotropins and sex steroids, which are reserved for certain diagnostic situations where there is any doubt, for example, premature ovarian failure syndrome.

He is currently a world consensus that the best available treatment for menopause is hormone replacement therapy because exogenously resets once the hormones produced by the ovaries. HRT fulfills several objectives: reverse neurovegetative symptoms, improves trophism genital atrophy and genital-urinary, acts in the prevention and treatment of osteoporosis, leading to lower incidence of colorectal cancer, promotes a later onset, lower incidence, evolution and improvement in symptoms of Alzheimer's disease has a positive influence on the view.

The development of HRT and the results that prove their individual benefits and epidemiological brought new questions about the most appropriate way to use the various schemes available. The treatment regimens are designed to establish a hormonal profile similar to that of premenopausal using: estrogens, progestogens and androgens in different doses and routes of administration.

Estrogens are the most commonly used conjugated estrogens. The subcutaneous implants (17 beta estradiol) The percutaneous estradiol in the form of gels, transdermal devices (patches) and Tibolone.

Hormones can be used alone or combined, cyclic or continuous, always trying to individualize each situation in order to provide patients with a regimen that suits your needs and desires.

Since its description in 1989, the extent of dilatation of the brachial artery flow-mediated (FMD) has been used to assess endothelial function. It is believed that ischemia induced by inflation of the cuff cause a dilation of the vessel, leading to an increase in brachial artery flow. This effect seems to be mediated by NO production by normal endothelial cells.

In patients whose bioactivity of NO is decreased or absent on endothelial function impairment, this dilatory response does not happen. The dilation of the brachial artery is thus higher in patients with normal endothelial function than in patients who have a pathology that leads to endothelial injury, among them, Hypertension, Coronary heart disease, diabetes mellitus, smoking, hyperlipidemia and Pre-Eclampsia.

Patients will be randomly divided into two groups of 30, using code envelope with the medication, without her or responsible for the study to know the component to be used (double-blind study), with groups divided as follows:

  • Group 1 placebo for 30 days;
  • Group 2: Tibolone 2.5 mg / day for 30 days Patients will be evaluated before the use of drugs and the end of their use (28-30 days of medication use).
Conditions
Menopause
Being tested
Tibolone, Placebo
Keywords
Tibolone, climacteric, Doppler, hormone replacement therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TiboloneDrug

    Also called Livial

    Experimental group will use 2.5mg of tibolone for 30 days

  • PlaceboDrug

    patients of the placebo group will use placebo one a day for 30 days

Study groups in NCT01543399
Study groupRoleWhat they receive
Tibolone useExperimentalclimacteric women will use Tibolone for 30 days
Receives: Drug: Tibolone
Placebo usePlacebo comparatorclimacteric women 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.

  1. Diameter measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of tibolone.

    We will evaluate the vascular effect of Tibolone on the brachial artery. The diameter of the artery will be measured before and one month after use of Tibolone and, in both situations, before and after the use of a cuff in the forearm. Measurement will be in millimeters.

    Measured: 30 days

Secondary outcomes (1)
  1. Patients symptoms before and after the use of Tibolone

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01543399
Sponsor's protocol ID
T.FR - 245365
Other IDs
ETIC0417
Acronym
TDILA
Status last verified
Apr 2015
First submitted
21 Feb 2012
Last updated
3 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • de Souza MA, de Souza BM, Geber S. Vascular resistance of central retinal and ophthalmic arteries in postmenopausal women after use of tibolone. Menopause. 2012 Mar;19(3):328-31. doi: 10.1097/gme.0b013e3182290b26.

    PubMed 22042323

Questions about this trial

What is this clinical trial studying?

A study testing Tibolone in people with Menopause, run by Selmo Geber 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?

Diameter measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of tibolone. (time frame: 30 days). 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 NCT01543399, 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 Apr 2015.

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