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Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use (DEXA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01579773
First Posted: April 18, 2012
Last Update Posted: December 10, 2014
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.
Information provided by (Responsible Party):
Washington University School of Medicine
April 10, 2012
April 18, 2012
December 10, 2014
April 2010
August 2014   (Final data collection date for primary outcome measure)
Weight [ Time Frame: Baseline and 12 months ]
Compare changes in body weight and BMI measurements
Weight [ Time Frame: 12 months ]
Compare changes in body weight and BMI measurements
Complete list of historical versions of study NCT01579773 on ClinicalTrials.gov Archive Site
Body composition [ Time Frame: Baseline and 12 months ]
Compare parameters including fat mass and percentage and central-to-peripheral fat ratios
Body composition [ Time Frame: 12 months ]
Compare parameters including fat mass and percentage and central-to-peripheral fat ratios
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Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use
Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Participants who are starting an IUD or implant through their provider could be eligible.
Weight Change
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
345
August 2014
August 2014   (Final data collection date for primary outcome measure)

The study has finished enrolling new participants.

Inclusion Criteria:

  • Participants between the ages of 18 and 45 years
  • Participants starting the copper IUD or implant through their provider
  • First study visit must occur within 14 days of method insertion

Exclusion Criteria:

  • DMPA in the past 16 weeks
  • POPs, LNG-IUC, or the implant in the past 4 weeks
  • Thyroid disease
  • Autoimmune disease
  • Diabetes (excluding gestational)
  • History of eating disorder
  • Currently taking antidepressants for < 6 months
  • Currently taking antipsychotics
  • Currently taking oral glucocorticoids (steroids, i.e. prednisone) for more than 6 months
  • Currently breastfeeding
  • Less than 6 months post-partum
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01579773
80158
No
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Washington University School of Medicine
Washington University School of Medicine
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Principal Investigator: Tessa E Madden, MD, MPH Washington University School of Medicine
Washington University School of Medicine
December 2014