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:
By phone
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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
Clinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
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 | ||||