Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
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ClinicalTrials.gov Identifier: NCT01679795 |
Recruitment Status :
Completed
First Posted : September 6, 2012
Last Update Posted : April 3, 2015
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Condition or disease | Intervention/treatment | Phase |
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Flow-mediated Dilation Evaluation of the Brachial Artery | Drug: Tibolone Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | February 2015 |
Arm | Intervention/treatment |
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Experimental: Tibolone
patientes will use tibolone 2,5mg/day during 30 days
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Drug: Tibolone
Other Name: Livial |
Placebo Comparator: Placebo use
Patients will use placebo for 30 days
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Drug: Placebo |
- 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

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Ages Eligible for Study: | 50 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679795
Brazil | |
hospital das Clinicas - Universidade Federal de Minas Gerais | |
belo Horizonte, minas Gerais, Brazil, 30130100 |
Responsible Party: | Selmo Geber, Associate Professor, Federal University of Minas Gerais |
ClinicalTrials.gov Identifier: | NCT01679795 |
Other Study ID Numbers: |
TDILA |
First Posted: | September 6, 2012 Key Record Dates |
Last Update Posted: | April 3, 2015 |
Last Verified: | April 2015 |
hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; tibolone |
Dilatation, Pathologic Pathological Conditions, Anatomical Tibolone Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Antihypertensive Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Estrogen Receptor Modulators Anabolic Agents Hormones |