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

Last updated: December 8, 2014
Sponsor: Washington University School of Medicine
Overall Status: Completed

Phase

N/A

Condition

Body Composition

Weight Loss

Treatment

N/A

Clinical Study ID

NCT01579773
80158
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 6months

  • Currently breastfeeding

  • Less than 6 months post-partum

Study Design

Total Participants: 345
Study Start date:
April 01, 2010
Estimated Completion Date:
August 31, 2014

Connect with a study center

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

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