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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depo-Provera Contraceptive Injection - DP150CI | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Bone Mineral Density in adolescent Depo-Provera Contraceptive | ||
| Injection (DP150CI) users will be evaluated and compared during depo | ||
| medroxyprogesterone acetate (DMPA) therapy and following discontinuation of | ||
| DMPA.Another group electing non-hormonal contraception or abstinence is | ||
| recruited as a reference population, across all study sites. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary variables are: Total Body Composition & Total Body Calcium (TBC), | ||
| measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD | ||
| markers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Los Angeles | California | United States | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Palo Alto |
| California |
| United States |
| Pfizer Investigational Site | Torrance | California | United States |
| Pfizer Investigational Site | Louisville | Kentucky | United States |
| Pfizer Investigational Site | Baltimore | Maryland | United States |
| Pfizer Investigational Site | Detroit | Michigan | United States |
| Pfizer Investigational Site | The Bronx | New York | United States |
| Pfizer Investigational Site | Cleveland | Ohio | United States |
| Pfizer Investigational Site | Columbus | Ohio | United States |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | United States |
| Pfizer Investigational Site | Providence | Rhode Island | United States |
| Pfizer Investigational Site | Norfolk | Virginia | United States |