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Vascular Effect of Tibolone in the Brachial Artery

NCT01543399 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-04-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tibolone

Experimental group will use 2.5mg of tibolone for 30 days

DRUG

Placebo

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

Sponsors & Collaborators

  • Selmo Geber

    lead OTHER

Principal Investigators

  • Selmo Geber, MD PhD · Federal University of Minas Gerais

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01543399 on ClinicalTrials.gov