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

Phase 4

Completed

• Conditions: Contraception; Bone Density

• Registration Number: NCT00139685
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-04
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-08-31
• Primary Completion: 2006-08
• Study Completion: 2007-07
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-23
• Last Update Posted: 2008-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary variables are: Total Body Composition & Total Body Calcium (TBC),
measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD
markers

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Norfolk, Virginia, United States