Depo-Provera: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150 CI Users and Matched Controls

NCT00139685 Phase 4 COMPLETED

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.

Details

Lead sponsor	Pfizer
Phase	Phase 4
Status	COMPLETED
Enrolment	350
Start date	1998-04
Completion	2007-07

Conditions

• Contraception
• Bone Density

Interventions

• Depo-Provera Contraceptive Injection - DP150CI

Primary outcomes

• 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.

Countries

United States