NCT00139685

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 1998

Longer than P75 for phase_4

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2008

Enrollment Period

8.3 years

First QC Date

August 29, 2005

Last Update Submit

September 23, 2008

Conditions

ContraceptionBone Density

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

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

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

  • markers

Interventions

Depo-Provera Contraceptive Injection - DP150CIDRUG

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescent females who have had any menses in the 6 months prior to enrollment
  • Must have a negative pregnancy test

You may not qualify if:

  • Screening Spinal BMD with z score not greater than -2 of matched young normals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pfizer Investigational Site

Los Angeles, California, United States

Location

Pfizer Investigational Site

Palo Alto, California, United States

Location

Pfizer Investigational Site

Torrance, California, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, United States

Location

Pfizer Investigational Site

Detroit, Michigan, United States

Location

Pfizer Investigational Site

The Bronx, New York, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, United States

Location

Pfizer Investigational Site

Columbus, Ohio, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, United States

Location

Pfizer Investigational Site

Providence, Rhode Island, United States

Location

Pfizer Investigational Site

Norfolk, Virginia, United States

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

April 1, 1998

Primary Completion

August 1, 2006

Study Completion

July 1, 2007

Last Updated

September 25, 2008

Record last verified: 2008-09

Locations

US(12)