Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception; Bone Density
Intervention: Depo-Provera Contraceptive Injection - DP150CI (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: Depo-Provera: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150 CI Users and Matched Controls
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Changes in Bone Mineral Density in adolescent Depo-Provera ContraceptiveInjection (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: Secondary variables are: Total Body Composition & Total Body Calcium (TBC),measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD markers
Eligibility
Minimum age: 12 Years.
Maximum age: 18 Years.
Gender(s): Female.
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
Locations and Contacts
Pfizer Investigational Site, Los Angeles, California, United States
Pfizer Investigational Site, Palo Alto, California, United States
Pfizer Investigational Site, Torrance, California, United States
Pfizer Investigational Site, Louisville, Kentucky, United States
Pfizer Investigational Site, Baltimore, Maryland, United States
Pfizer Investigational Site, Detroit, Michigan, United States
Pfizer Investigational Site, Bronx, New York, United States
Pfizer Investigational Site, Cleveland, Ohio, United States
Pfizer Investigational Site, Columbus, Ohio, United States
Pfizer Investigational Site, Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site, Providence, Rhode Island, United States
Pfizer Investigational Site, Norfolk, Virginia, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 1998
Last updated: September 23, 2008
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