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

NCT00139685

Last updated date
Study Location
Pfizer Investigational Site
Los Angeles, California, , United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Contraception, Bone Density
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-18 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adolescent females who have had any menses in the 6 months prior to enrollment

- Must have a negative pregnancy test

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Contraception, Bone DensityDepo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception
NCT00139685
  1. Los Angeles, California
  2. Palo Alto, California
  3. Torrance, California
  4. Louisville, Kentucky
  5. Baltimore, Maryland
  6. Detroit, Michigan
  7. Bronx, New York
  8. Cleveland, Ohio
  9. Columbus, Ohio
  10. Pittsburgh, Pennsylvania
  11. Providence, Rhode Island
  12. Norfolk, Virginia
Female
12 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception
Official Title  ICMJE Depo-Provera: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150 CI Users and Matched Controls
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Contraception
  • Bone Density
Intervention  ICMJE Drug: Depo-Provera Contraceptive Injection - DP150CI
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 30, 2005)
350
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00139685
Other Study ID Numbers  ICMJE Z54000261
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP