CompletedPhase 3

Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects

United States34 participantsStarted 2011-09

Plain-language summary

The investigators are doing this study to look at how different doses of the Depot medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens. The investigators hope that what the investigators learn from this study will be used to develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.

Who can participate

Age range12 Years – 21 Years

SexFEMALE

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Inclusion criteria

✓. Age 12-21 years
✓. Healthy, post-menarcheal female
✓. Self-selected to initiate depot medroxyprogesterone acetate (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 within the past 12 months
✕. Pregnancy within the past 6 months
✕. Etonogestrel implant, levonorgestrel-releasing intrauterine system or combined estrogen/progesterone contraceptive use within the past 30 days (OC, patch, vaginal ring)
✕. Weight exceeding 450 lbs
✕. Need for confidential contraceptive care for individuals \< 18 years of age.

What they're measuring

Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks

Timeframe: Percent change from baseline to 48 Weeks

Proportion of Participants With >5% Weight Gain at 24 Weeks

Timeframe: Week 24

Trial details

NCT IDNCT01461824

SponsorNationwide Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-04

Results submitted2017-10-11

View on ClinicalTrials.gov More Weight Gain trials