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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 25, 2014