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Vascular Effect of Estradiol Valerate Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery (VEDILA)

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ClinicalTrials.gov Identifier: NCT02161614
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais

Tracking Information
First Submitted Date  ICMJE June 10, 2014
First Posted Date  ICMJE June 12, 2014
Last Update Posted Date January 15, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
Flow-mediated dilation of the brachial artery [ Time Frame: 30 days after treatment started ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vascular Effect of Estradiol Valerate Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
Official Title  ICMJE Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol Valerate and Placebo. Randomized, Double Blinded, Placebo Controlled Study.
Brief Summary The aim of this study is to evaluate the vascular effects of estradiol valerate on climacteric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.
Detailed Description The interruption of the secretion of sex steroids that occurs after menopause, determines a change in vascular pattern at various levels. As a result, several side effects might appear and interfere with women's quality of life and health. The use of hormone replacement therapy has contributed to the improvement in these effects. It has been observed vascular beneficial effects of sex steroids in premenopausal women, and of hormone replacement therapy (HRT) in climacteric women, on the central retinal arteries. The objective of this study is to evaluate the effects of estradiol valerate on flow-mediated dilation of the brachial artery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Flow-mediated Dilation Evaluation of the Brachial Artery
Intervention  ICMJE
  • Drug: Estradiol valerate
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Patients will use placebo for 30 days
    Intervention: Drug: Placebo
  • Experimental: Estradiol Valerate
    patients will use estradiol valerate 1mg/day during 30 days
    Intervention: Drug: Estradiol valerate
Publications * Faria AF, de Souza MA, Geber S. Vascular resistance of central retinal artery is reduced in postmenopausal women after use of estrogen. Menopause. 2011 Aug;18(8):869-72. doi: 10.1097/gme.0b013e31820cc60c.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women without menstrual cycles within the last 12 months and follicle stimulating hormone (FSH)>30International Units / Liter
  • Healthy women
  • Women that were not using drugs with potential vascular effect within 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02161614
Other Study ID Numbers  ICMJE DILA V E2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Selmo Geber, Federal University of Minas Gerais
Study Sponsor  ICMJE Federal University of Minas Gerais
Collaborators  ICMJE Fundação de Amparo à Pesquisa do estado de Minas Gerais
Investigators  ICMJE
Principal Investigator: Selmo Geber, MD PhD Federal University of Minas Gerais
PRS Account Federal University of Minas Gerais
Verification Date January 2016

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