Chronic Effects of Estrogen in Microcirculation
1 other identifier
interventional
44
1 country
1
Brief Summary
This study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese women after three months of follow-up intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2011
CompletedFirst Posted
Study publicly available on registry
February 15, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedApril 18, 2013
April 1, 2013
1.2 years
February 14, 2011
April 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
functional capillary density by videocapillaroscopy(number of perfused capillaries on the studied skin area)
03 months
Secondary Outcomes (1)
blood viscosity(the values are expressed in centipoises)
03 months
Study Arms (2)
placebo
PLACEBO COMPARATORplacebo (transdermal gel)
Estrogen
EXPERIMENTAL1mg of 17B-estradiol/day (transdermal gel)
Interventions
Eligibility Criteria
You may qualify if:
- History of natural menopause defined by the absence of menses for at least 12 months and a serum concentration of FSH \> 35 IU/L
- BMI between 27 to 34.9 kg/m²
- Non-smokers
- Not on use of any hormones or supplements for a minimum of 6 months prior to the study
- No absolute contraindications to the use of physiological replacement doses of estrogen
You may not qualify if:
- Renal disease, coronary or peripheral vascular diseases, haematologic or hepatic diseases
- Diabetes mellitus, glucose intolerance or altered fasting glucose
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular
Rio de Janeiro, Brazil
Related Publications (1)
da Silva LH, Panazzolo DG, Marques MF, Souza MG, Paredes BD, Nogueira Neto JF, Leao LM, Morandi V, Bouskela E, Kraemer-Aguiar LG. Low-dose estradiol and endothelial and inflammatory biomarkers in menopausal overweight/obese women. Climacteric. 2016 Aug;19(4):337-43. doi: 10.1080/13697137.2016.1180676. Epub 2016 May 12.
PMID: 27170466DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diogo Panazzolo
Rio de Janeiro State University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chronic Effects of Estrogen in Microcirculation and Insulin Resistance in Postmenopausal Obese Women
Study Record Dates
First Submitted
February 14, 2011
First Posted
February 15, 2011
Study Start
December 1, 2011
Primary Completion
March 1, 2013
Study Completion
April 1, 2013
Last Updated
April 18, 2013
Record last verified: 2013-04