Status:
COMPLETED
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
Society of Family Planning
Conditions:
Weight Gain
Disorder of Bone Density and Structure, Unspecified
Eligibility:
FEMALE
12-21 years
Phase:
PHASE3
Brief 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 ...
Detailed 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 bon...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01461824
Start Date
September 1 2011
End Date
July 1 2016
Last Update
April 23 2018
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205