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

NCT00139685 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2008-09-25

No results posted yet for this study

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.

Conditions

  • Contraception
  • Bone Density

Interventions

DRUG

Depo-Provera Contraceptive Injection - DP150CI

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1998-04-30
Primary Completion
2006-08-31
Completion
2007-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00139685 on ClinicalTrials.gov