drugset / Trial / NCT00139685

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

NCT00139685

Phase 4 Completed 350 enrolled Pfizer
RandomizedParallel-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start
1998-04
Primary completion
2006-08
Completion
2007-07

Drugs

EvaluationDrugModalityDoseRoute
Subject medroxyprogesterone acetate Other / unclassified

Indications

No indication recorded.