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

NCT01461824 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-04-23

Study results available
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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.

Conditions

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

Interventions

DRUG

Depot medroxyprogesterone acetate (DMPA)

75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months

Sponsors & Collaborators

Principal Investigators

  • Andrea Bonny, MD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-04-30
Completion
2016-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01461824 on ClinicalTrials.gov