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

Completed · Phase 3

Conditions studied: Weight Gain, Disorder of Bone Density and Structure, Unspecified, Uterine Bleeding

In brief

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.

Key facts

Study ID

NCT01461824

Run by

Nationwide Children's Hospital

People needed

34

Starts

2011-09-01

Expected to finish

2016-07-01

Last updated by the study team

2018-04-23

Who can join

Age: 12 and older, up to 21. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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