Characteristics of ongoing studies

Bonny 2012
Study name	Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
Methods	Randomized, open-label; pharmacokinetic study. Purpose: learn whether DMPA affects weight gain and bone mineral density in teens.
Participants	45 healthy young women Inclusion criteria: healthy, postmenarchal females. age 12 to 21 years; self-selected to initiate DMPA; willingness to use a barrier method of contraception in addition to DMPA. Exclusion criteria: chronic disease known to affect weight or bone mineral density (BMD) (e.g. diabetes, kidney); use of medication known to affect weight or BMD (e.g. corticosteroids); DMPA use in past 12 months; pregnancy in past 6 months; etonogestrel implant, levonorgestrel-releasing intrauterine system or combined estrogen/progesterone contraceptive in past 3 months (OC, patch, vaginal ring); weight > 250 lbs; need for confidential contraceptive care for individuals < 18 years of age.
Interventions	DMPA, intramuscular injection 150 mg; approved for use (US Food and Drug Administration (FDA)) when given into muscle. 104 mg; FDA-approved for use only when given under the skin; therefore considered experimental. 75 mg; considered experimental; not FDA-approved regardless of how given.
Outcomes	> 5% weight gain at 24 weeks; > 10% weight gain at 48 weeks.
Starting date	Sep 2011. Estimated completion: Dec 2013.
Contact information	Lauren Bird, RN; 614-722-2650; Lauren.Bird@NationwideChildrens.org Hannah Lange, MPH; 614-722-3465; Hannah.Lange@NationwideChildrens.org Principal Investigator: Andrea Bonny, MD
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Madden 2012b
Study name	Comparison of Body Composition &Weight Change in Users of Progestin-only Contraception During the First Year of Use (DEXA)
Methods	Observational prospective cohort; non-probability sample. Purpose: learn if women gain weight using progestin-only methods of contraception and if so, how much.
Participants	345 women Inclusion criteria: women aged 18 to 45 years, starting the copper IUD or implant through their provider, first study visit must occur within 14 days of method insertion. Exclusion criteria: DMPA in past 16 weeks; POPs, LNG-IUC, or implant in past 4 weeks; thyroid disease, autoimmune disease, diabetes (excluding gestational); history of eating disorder; currently taking antidepressants for < 6 months, antipsychotics; oral glucocorticoids (steroids, i.e. prednisone) for > 6 months; currently breastfeeding or < 6 months postpartum.
Interventions	Levonorgestrel-containing intrauterine contraceptive (LNG-IUC) Etonogestrel (ENG) subdermal implant Copper IUD.
Outcomes	Weight change at 12 months; compare changes in body weight and BMI. Body composition assessed with dual-energy x-ray absorptiometry (DEXA); diet and activity via validated questionnaires.
Starting date	April 2010; estimated completion Jan 2013
Contact information	Danielle S Grunloh, BS; 314-747-1425; grunlohd@wudosis.wustl.edu Tessa E Madden, MD, MPH; Washington University School of Medicine
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