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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01579773
First received: April 10, 2012
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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
Weight Change

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Weight [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Compare changes in body weight and BMI measurements


Secondary Outcome Measures:
  • Body composition [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Compare parameters including fat mass and percentage and central-to-peripheral fat ratios


Estimated Enrollment: 345
Study Start Date: April 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01579773     History of Changes
Other Study ID Numbers: 80158
Study First Received: April 10, 2012
Last Updated: July 24, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014