Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Contraception

Bone Density

Eligibility:

FEMALE

12-18 years

Phase:

PHASE4

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 discontinuati...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

April 1 1998

Trial Type :

INTERVENTIONAL

End Date :

July 1 2007

Estimated Enrollment :

350 Patients enrolled

Trial Details

Trial ID

NCT00139685

Start Date

April 1 1998

End Date

July 1 2007

Last Update

September 25 2008

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Pfizer Investigational Site

Los Angeles, California, United States

2

Pfizer Investigational Site

Palo Alto, California, United States

3

Pfizer Investigational Site

Torrance, California, United States

4

Pfizer Investigational Site

Louisville, Kentucky, United States