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

Overview

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.

Full Title of Study: “Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2014

Clinical Trial Outcome Measures

Primary Measures

  • Weight
    • Time Frame: Baseline and 12 months
    • Compare changes in body weight and BMI measurements

Secondary Measures

  • Body composition
    • Time Frame: Baseline and 12 months
    • Compare parameters including fat mass and percentage and central-to-peripheral fat ratios

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tessa E Madden, MD, MPH, Principal Investigator, Washington University School of Medicine

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