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.

Condition	Intervention	Phase
Contraception Bone Density	Drug: Depo-Provera Contraceptive Injection - DP150CI	Phase IV

Further Study Details: 

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-ho
Secondary Outcomes: Secondary variables are:; Total Body Composition & Total Body Calcium (TBC), measured by Dual Energy X-ray Absorptiometry (DXA); Surrogate biologic BMD markers; Safety will be evaluated by:; Adverse event reporting; Laboratory evaluations; Pregnancies; Weight
Expected Total Enrollment:  350

Ages Eligible for Study:  12 Years   -   18 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00139685

Pfizer CT.gov Call Center      1-800-718-1021 

California
      Pfizer Investigational Site, Palo Alto,  California,  94304,  United States; Recruiting
      Pfizer Investigational Site, Los Angeles,  California,  90059,  United States; Completed
      Pfizer Investigational Site, Los Angeles,  California,  90221,  United States; Completed
      Pfizer Investigational Site, Torrance,  California,  90502,  United States; Recruiting
Kentucky
      Pfizer Investigational Site, Louisville,  Kentucky,  40202,  United States; Recruiting
Maryland
      Pfizer Investigational Site, Baltimore,  Maryland,  21287,  United States; No longer recruiting
Michigan
      Pfizer Investigational Site, Detroit,  Michigan,  48201,  United States; Recruiting
New York
      Pfizer Investigational Site, Bronx,  New York,  10461,  United States; Recruiting
      Pfizer Investigational Site, Bronx,  New York,  10467,  United States; Recruiting
Ohio
      Pfizer Investigational Site, Columbus,  Ohio,  43205,  United States; Recruiting
      Pfizer Investigational Site, Columbus,  Ohio,  United States; Recruiting
      Pfizer Investigational Site, Cleveland,  Ohio,  44109,  United States; Recruiting
Pennsylvania
      Pfizer Investigational Site, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Rhode Island
      Pfizer Investigational Site, Providence,  Rhode Island,  02903,  United States; Recruiting
Virginia
      Pfizer Investigational Site, Norfolk,  Virginia,  23505,  United States; Completed
      Pfizer Investigational Site, Norfolk,  Virginia,  23507,  United States; Completed

Study chairs or principal investigators

Pfizer Call Center,  Study Director,  Pfizer   

Study ID Numbers:  Z54000261
Last Updated:  August 30, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00139685
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06