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

NCT ID: NCT00139685

Last Updated: 2008-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Contraception Bone Density

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Depo-Provera Contraceptive Injection - DP150CI

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Palo Alto, California, United States

Site Status

Pfizer Investigational Site

Torrance, California, United States

Site Status

Pfizer Investigational Site

Louisville, Kentucky, United States

Site Status

Pfizer Investigational Site

Baltimore, Maryland, United States

Site Status

Pfizer Investigational Site

Detroit, Michigan, United States

Site Status

Pfizer Investigational Site

The Bronx, New York, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Pfizer Investigational Site

Columbus, Ohio, United States

Site Status

Pfizer Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Providence, Rhode Island, United States

Site Status

Pfizer Investigational Site

Norfolk, Virginia, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=Z54000261&StudyName=Depo%2DProvera%3A+Evaluation+of+BMDensity+and+Total+Body+Ca+Adolescent+DP150CI+Users+and+Non%2Dhormonal+Contraception

To obtain contact information for a study center near you, click here.

Other Identifiers

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Z54000261

Identifier Type: -

Identifier Source: org_study_id

NCT00264836

Identifier Type: -

Identifier Source: nct_alias