DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception; Bone Density

Intervention: Depo-Provera Contraceptive Injection - DP150CI (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome:

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:

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

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

markers

Eligibility

Minimum age: 12 Years. Maximum age: 18 Years. Gender(s): Female.

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

Locations and Contacts

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, 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

Pfizer Investigational Site, Providence, Rhode Island, United States

Pfizer Investigational Site, Norfolk, Virginia, United States

Additional Information

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

Starting date: April 1998
Last updated: September 23, 2008

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017