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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139685
First received: August 29, 2005
Last updated: September 23, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Contraception
Bone Density
Drug: Depo-Provera Contraceptive Injection - DP150CI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Depo-Provera: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150 CI Users and Matched Controls

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome 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 Outcome Measures:
  • Secondary variables are: Total Body Composition & Total Body Calcium (TBC),
  • measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD
  • markers

Estimated Enrollment: 350
Study Start Date: April 1998
Study Completion Date: July 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139685

Locations
United States, California
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
Torrance, California, United States
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States
United States, New York
Pfizer Investigational Site
Bronx, New York, United States
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Columbus, Ohio, United States
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States
United States, Virginia
Pfizer Investigational Site
Norfolk, Virginia, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00139685     History of Changes
Obsolete Identifiers: NCT00264836
Other Study ID Numbers: Z54000261
Study First Received: August 29, 2005
Last Updated: September 23, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Contraceptive Agents
Medroxyprogesterone
Medroxyprogesterone Acetate
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014