Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception
NCT00139685
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Contraception, Bone Density
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
12-18 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Adolescent females who have had any menses in the 6 months prior to enrollment
- Must have a negative pregnancy test
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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Contraception, Bone DensityDepo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception
NCT00139685
- Los Angeles, California
- Palo Alto, California
- Torrance, California
- Louisville, Kentucky
- Baltimore, Maryland
- Detroit, Michigan
- Bronx, New York
- Cleveland, Ohio
- Columbus, Ohio
- Pittsburgh, Pennsylvania
- Providence, Rhode Island
- Norfolk, Virginia
Female
12 Years+
years
MULTIPLE SITES
Advanced Information
| 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 | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: Depo-Provera Contraceptive Injection - DP150CI | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 350 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | July 2007 | |||
| Actual Primary Completion Date | August 2006 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 12 Years to 18 Years (Child, Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00139685 | |||
| Other Study ID Numbers ICMJE | Z54000261 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | September 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||