Vascular Effect of Tibolone in the Brachial Artery
Condition: Menopause
Study type: Interventional

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. 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.
    

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).
    

Intervention name(s): Tibolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Experimental group will use 2.5mg of tibolone for 30 days; patients of the placebo group will use placebo one a day for 30 days
Other intervention name(s): Livial
Intervention MeSH terms: Tibolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tibolone; climacteric; Doppler; hormone replacement therapy