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

Weight Gain Clinical Trial

Official title: Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Bone Diseases
• Disorder of Bone Density and Structure, Unspecified
• Uterine Bleeding
• Uterine Hemorrhage
• Weight Gain

• NCT number: NCT01461824
• Study type: Interventional
• Source: Nationwide Children's Hospital
• Status: Completed
• Phase: Phase 3
• Start date: September 2011
• Completion date: July 2016