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

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ClinicalTrials.gov Identifier: NCT01579773
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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
Weight Change

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 : April 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Weight [ Time Frame: Baseline and 12 months ]
    Compare changes in body weight and BMI measurements


Secondary Outcome Measures :
  1. Body composition [ Time Frame: Baseline and 12 months ]
    Compare parameters including fat mass and percentage and central-to-peripheral fat ratios



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants who are starting an IUD or implant through their provider could be eligible.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579773


Locations
United States, Missouri
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

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01579773     History of Changes
Other Study ID Numbers: 80158
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Signs and Symptoms
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs