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Completed

NCT Number: NCT00139685

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 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.

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Key information

Conditions

Contraception Bone Density

Age range

12 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Depo-Provera Contraceptive Injection - DP150CI

Drug

Primary outcomes

  1. Changes in Bone Mineral Density in adolescent Depo-Provera Contraceptive

  2. Injection (DP150CI) users will be evaluated and compared during depo

  3. medroxyprogesterone acetate (DMPA) therapy and following discontinuation of

  4. DMPA.Another group electing non-hormonal contraception or abstinence is

  5. recruited as a reference population, across all study sites.

Secondary outcomes

  1. Secondary variables are: Total Body Composition & Total Body Calcium (TBC),

  2. measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD

  3. markers

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Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Depo-Provera: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150 CI Users and Matched Controls

Important dates

Study start
1998
Primary completion
2006
Study completion
2007
First posted
Aug 31, 2005
Registry last updated
Sep 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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