NCT00139685

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (planned)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 12 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contraception
• Bone Density

Interventions

Type	Name	Description
DRUG	Depo-Provera Contraceptive Injection - DP150CI

Timeline

• Start date: 1998-04-01
• Primary completion: 2006-08-01
• Completion: 2007-07-01
• First posted: 2005-08-31
• Last updated: 2008-09-25

Locations

12 sites across 1 country: United States