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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.
Age
12 - 18 years
Sex
FEMALE
Healthy Volunteers
Yes
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Detroit, Michigan, United States
Pfizer Investigational Site
The Bronx, New York, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Columbus, Ohio, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Start Date
April 1, 1998
Primary Completion Date
August 1, 2006
Completion Date
July 1, 2007
Last Updated
September 25, 2008
350
Estimated participants
Depo-Provera Contraceptive Injection - DP150CI
DRUG
Lead Sponsor
Pfizer
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06672016