Clinical Trials Directory

Trials / Completed

CompletedNCT01527526

Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism

Prospective Study for Evaluation of the Insulin Resistance, Lipid Metabolism and Sub Clinical Cardiovascular Disease in Women Who Initiate the Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method With in Follow-up for Two Years

Status
Completed
Phase
Study type
Observational
Enrollment
54 (actual)
Sponsor
University of Campinas, Brazil · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Accepted

Summary

Objective: The purpose of this study is to determine the etiology of the weight increase in Depot-medroxyprogesterone Acetate (DMPA) users. Method: Prospective study with 100 women, aged 18-40 years old and BMI \< 30kg/m², paired with users of a non hormonal method follow for two years. Will be included only women who never used DMPA. There will be evaluated habit, blood pressure, anthropometric measure, distribution of corporal fat, lipids profile and glycemia parameters every six months. Thirty women and their control group will performed a euglycemic-hyperinsulinemic clamp to evaluate the resistance of insulin, adiponectin,neuropeptide Y, apolipoprotein A/B and arterial evaluation with ultrasound, intimal and media measure. Anova analysis for repeated samples. The metabolic alterations should elucidate the etiology, and the beginning of the sub clinical cardiovascular disease should be shown/discarded with the arterial evaluation.

Conditions

Timeline

Start date
2011-02-01
Primary completion
2013-02-01
Completion
2013-02-01
First posted
2012-02-07
Last updated
2015-06-04

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01527526. Inclusion in this directory is not an endorsement.