Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception

Completed · Phase 4

Conditions studied: Contraception, Bone Density

In brief

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.

Key facts

Study ID

NCT00139685

Run by

Pfizer

People needed

350

Starts

1998-04-01

Expected to finish

2007-07-01

Last updated by the study team

2008-09-25

Who can join

Age: 12 and older, up to 18. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Adolescent females who have had any menses in the 6 months prior to enrollment
• Must have a negative pregnancy test

You may not qualify if…

• Concomitant medication exclusion use of bone modifying agents, glucocorticoids, heparin, and anticonvulsants
• Screening Spinal BMD with z score not greater than -2 of matched young normals

Where it is running

• 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
• Pfizer Investigational Site — Providence, Rhode Island, United States
• Pfizer Investigational Site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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