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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01579773
First received: April 10, 2012
Last updated: July 24, 2013
Last verified: July 2013

April 10, 2012
July 24, 2013
April 2010
July 2014   (final data collection date for primary outcome measure)
Weight [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
Compare changes in body weight and BMI measurements
Weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Compare parameters including fat mass and percentage and central-to-peripheral fat ratios
Body composition [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.

Not Provided
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.
 
Active, not recruiting
345
July 2014
July 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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01579773
80158
No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Tessa E Madden, MD, MPH Washington University School of Medicine
Washington University School of Medicine
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP