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NCT00139685 Clinical Trial

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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00139685
Other study ID # Z54000261
Secondary ID
Status Completed
Phase Phase 4
First received August 29, 2005
Last updated September 23, 2008
Start date April 1998
Est. completion date July 2007

Study information
Verified date September 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Other known NCT identifiers
  • NCT00264836

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date July 2007
Est. primary completion date August 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 12 Years to 18 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Depo-Provera Contraceptive Injection - DP150CI

Locations
Country Name City State
United States Pfizer Investigational Site Baltimore Maryland
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 Detroit Michigan
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site Palo Alto California
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Providence Rhode Island
United States Pfizer Investigational Site Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in Bone Mineral Density in adolescent Depo-Provera Contraceptive
Primary Injection (DP150CI) users will be evaluated and compared during depo
Primary medroxyprogesterone acetate (DMPA) therapy and following discontinuation of
Primary DMPA.Another group electing non-hormonal contraception or abstinence is
Primary recruited as a reference population, across all study sites.
Secondary Secondary variables are: Total Body Composition & Total Body Calcium (TBC),
Secondary measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD
Secondary markers
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