Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
- Study Primary Completion Date: August 2006
Intervention(s) in this Clinical Trial
- Drug: Depo-Provera Contraceptive Injection - DP150CI
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Pfizer Industry
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00139685
