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

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.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Study Primary Completion Date: August 2006

Intervention(s) in this Clinical Trial

• Drug: Depo-Provera Contraceptive Injection - DP150CI

Primary Measures

• 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 Measures

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

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00139685

Study ID Number: Z54000261

ClinicalTrials.gov Identifier: NCT00139685

Health Authority: United States: Food and Drug Administration

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Link to ClinicalStudyResults.org posting.