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

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01579773
Collaborator
(none)
345
Enrollment
1
Location
52
Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    345 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use
    Study Start Date :
    Apr 1, 2010
    Actual Primary Completion Date :
    Aug 1, 2014
    Actual Study Completion Date :
    Aug 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Weight [Baseline and 12 months]

      Compare changes in body weight and BMI measurements

    Secondary Outcome Measures

    1. Body composition [Baseline and 12 months]

      Compare parameters including fat mass and percentage and central-to-peripheral fat ratios

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine

    Investigators

    • Principal Investigator: Tessa E Madden, MD, MPH, Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT01579773
    Other Study ID Numbers:
    • 80158
    First Posted:
    Apr 18, 2012
    Last Update Posted:
    Dec 10, 2014
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:
    Body Weight
    Body Weight Changes

    Study Results

    No Results Posted as of Dec 10, 2014