Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use (DEXA)
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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 |
- Weight [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Compare changes in body weight and BMI measurements
- 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: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (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 |
Participants who are starting an IUD or implant through their provider could be eligible.
The study has finished enrolling LNG-IUC users but is still recruiting copper-IUD and implant users for participation.
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| Contact: Danielle S Grunloh, BS | 314-747-1425 | grunlohd@wudosis.wustl.edu |
| Contact: Tessa E Madden, MD, MPH |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| 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 30, 2012 |
| 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 May 16, 2013