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

Tracking Information

First Received Date ^ICMJE

August 29, 2005

Last Updated Date

September 23, 2008

Start Date ^ICMJE

April 1998

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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-ho

Change History

Complete list of historical versions of study NCT00139685 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Secondary variables are:
Total Body Composition & Total Body Calcium (TBC), measured by Dual Energy X-ray Absorptiometry (DXA)
Surrogate biologic BMD markers
Safety will be evaluated by:
Adverse event reporting
Laboratory evaluations
Pregnancies
Weight

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Contraception
Bone Density

Intervention ^ICMJE

Drug: Depo-Provera Contraceptive Injection - DP150CI

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

350

Completion Date

July 2007

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

12 Years to 18 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00139685

Responsible Party

Director, Clinical Trial Disclosure, Pfizer, Inc.

Study ID Numbers ^ICMJE

Z54000261

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP