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

Weight Loss

Body Composition

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

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.