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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00139685
• Collaborator: (none)
• Enrollment: 350
• Locations: 12
• Duration (Months): 111
• Patients Per Site: 29.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception; Bone Density	Drug: Depo-Provera Contraceptive Injection - DP150CI	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Depo-Provera: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150 CI Users and Matched Controls
• Study Start Date: Apr 1, 1998
• Actual Primary Completion Date: Aug 1, 2006
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

1. Changes in Bone Mineral Density in adolescent Depo-Provera Contraceptive []

2. Injection (DP150CI) users will be evaluated and compared during depo []

3. medroxyprogesterone acetate (DMPA) therapy and following discontinuation of []

4. DMPA.Another group electing non-hormonal contraception or abstinence is []

5. recruited as a reference population, across all study sites. []

Secondary Outcome Measures

1. Secondary variables are: Total Body Composition & Total Body Calcium (TBC), []

2. measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD []

3. markers []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Los Angeles	California	United States
2	Pfizer Investigational Site	Palo Alto	California	United States
3	Pfizer Investigational Site	Torrance	California	United States
4	Pfizer Investigational Site	Louisville	Kentucky	United States
5	Pfizer Investigational Site	Baltimore	Maryland	United States
6	Pfizer Investigational Site	Detroit	Michigan	United States
7	Pfizer Investigational Site	Bronx	New York	United States
8	Pfizer Investigational Site	Cleveland	Ohio	United States
9	Pfizer Investigational Site	Columbus	Ohio	United States
10	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States
11	Pfizer Investigational Site	Providence	Rhode Island	United States
12	Pfizer Investigational Site	Norfolk	Virginia	United States

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00139685
• Other Study ID Numbers: Z54000261; NCT00264836
• First Posted: Aug 31, 2005
• Last Update Posted: Sep 25, 2008
• Last Verified: Sep 1, 2008

• Additional relevant MeSH terms: Medroxyprogesterone Acetate; Contraceptive Agents; Medroxyprogesterone

Study Results

No Results Posted as of Sep 25, 2008