To evaluate and compare Bone Mineral Density (BMD) in adolescent Depo-Provera Contraceptive Injection (DP150CI) users during depo medroxyprogesterone acetate (DMPA) therapy and following discontinuation of DMPA. Another group electing non-hormonal contraception or abstinence will be recruited as a reference population, across all study sites. The primary variable is BMD, measured by Dual Energy X-ray Absorptiometry (DXA). Secondary variables are: Total Body Composition\& Total Body Calcium (TBC), measured by Dual Energy X-ray Absorptiometry (DXA), and surrogate biologic BMD markers. Safety will be evaluated by adverse event reporting, laboratory evaluations, pregnancies, weight and vital signs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
350
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Detroit, Michigan, United States
Pfizer Investigational Site
The Bronx, New York, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Columbus, Ohio, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
...and 2 more locations
Changes in Bone Mineral Density in adolescent Depo-Provera Contraceptive
Injection (DP150CI) users will be evaluated and compared during depo
medroxyprogesterone acetate (DMPA) therapy and following discontinuation of
DMPA.Another group electing non-hormonal contraception or abstinence is
recruited as a reference population, across all study sites.
Secondary variables are: Total Body Composition & Total Body Calcium (TBC),
measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD
markers
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