Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
NCT Number: NCT01461824
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.
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Notify Me12 year–21 year
Female
Interventional
Phase 3
Columbus, Ohio, 43205, United States
Depot medroxyprogesterone acetate (DMPA) is a generic form of the DepoProvera® shot. When receiving the birth control shot some girls gain a lot of weight while others do not. Some girls also lose bone mineral density (BMD). Bone mineral density is the amount of weight and thickness of the bones.
In this study 1 of 3 doses of DMPA will be given as an injection into the muscle in the arm. The 150mg dose is approved for use in this age group by the Food and Drug Administration (FDA) when given into the muscle. The 104mg dose is approved for use in this age group by the FDA only when given under the skin therefore it is considered experimental. The 75mg dose is also considered experimental as this dose is not FDA approved regardless of how it is given.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Other names: Generic Depo Provera manufactured by Greenstone, LLC
Time frame: Percent change from baseline to 48 Weeks
Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated.
Time frame: Week 24
Individual subjects will be assessed after their Week 24 visit.
Time frame: Percent change from baseline to 48 weeks
Total hip bone mineral density was assessed at baseline and 48 weeks. Percent change from baseline to 48 weeks was calculated.
Nationwide Children's Hospital
Other
Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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