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

This study is currently recruiting participants.
Verified September 2012 by Federal University of Minas Gerais
Sponsor:
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01679795
First received: September 3, 2012
Last updated: September 5, 2012
Last verified: September 2012

September 3, 2012
September 5, 2012
February 2012
February 2013   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Flow-mediated dilation will be measured by high resolution ultrasound
Same as current
Complete list of historical versions of study NCT01679795 on ClinicalTrials.gov Archive Site
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Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
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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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Flow-mediated Dilation Evaluation of the Brachial Artery
  • Drug: Tibolone
    Other Name: Livial
  • Drug: Placebo
  • Experimental: Tibolone
    patientes will use tibolone 2,5mg/day during 30 days
    Intervention: Drug: Tibolone
  • Placebo Comparator: Placebo use
    Patients will use placebo for 30 days
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Female
50 Years to 65 Years
Yes
Contact: Selmo Geber, MD PhD 55 31 34099304 sjgeber@terra.com.br
Contact: Myrian Celani, MD 55 31 34099764 myriancelani@gmail.com
Brazil
 
NCT01679795
TDILA
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Selmo Geber, Federal University of Minas Gerais
Federal University of Minas Gerais
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Not Provided
Federal University of Minas Gerais
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP