Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use (DEXA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01579773|
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : December 10, 2014
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||345 participants|
|Official Title:||Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
- Weight [ Time Frame: Baseline and 12 months ]Compare changes in body weight and BMI measurements
- Body composition [ Time Frame: Baseline and 12 months ]Compare parameters including fat mass and percentage and central-to-peripheral fat ratios
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): 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|