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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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NCT00139685

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Los Angeles, California, United States
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Contact
1-800-718-1021
[email protected]
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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

NCT00139685
Pfizer
Completed
Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception

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Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Contraception
  • Bone Density
Drug: Depo-Provera Contraceptive Injection - DP150CI
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
July 2007
August 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
12 Years to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00139685
Z54000261
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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