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Trial record 1 of 1 for:    NCT00139685
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Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception

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ClinicalTrials.gov Identifier: NCT00139685
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : September 25, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 29, 2005
First Posted Date  ICMJE August 31, 2005
Last Update Posted Date September 25, 2008
Study Start Date  ICMJE April 1998
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2006)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2006)
  • Secondary variables are: Total Body Composition & Total Body Calcium (TBC),
  • measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD
  • markers
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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