Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use (DEXA)
The purpose of this study is to learn if women gain weight using progestin-only methods of contraception and if so, how much. The investigators will look at users of two progestin-only methods: the levonorgestrel-containing intrauterine contraceptive (LNG-IUC) and the etonorgestrel (ENG) subdermal implant, and compare these users' weight change to that of users of a non-hormonal method, the copper intrauterine device.
The primary hypothesis is that ENG implant and LNG-IUC users' weight and body composition will increase more than the copper-IUD users. The investigators will collect body composition data using dual-energy x-ray absorptiometry (DEXA), and collect information about diet and activity using validated questionnaires.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use|
- Weight [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Compare changes in body weight and BMI measurements
- Body composition [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Compare parameters including fat mass and percentage and central-to-peripheral fat ratios
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579773
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Tessa E Madden, MD, MPH||Washington University School of Medicine|