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



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 45
Updated:7/16/2013
Start Date:April 2010
End Date:July 2014
Contact:Danielle S Grunloh, BS
Email:grunlohd@wudosis.wustl.edu
Phone:314-747-1425

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
1
site
Washington University School of Medicine
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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