Bone Density, Contraception
Conditions
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.
Interventions
DRUGDepo-Provera Contraceptive Injection - DP150CI
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recruited as a reference population, across all study sites. | — |
| 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 | — |
| Changes in Bone Mineral Density in adolescent Depo-Provera Contraceptive | — |
Secondary
| Measure | Time frame |
|---|---|
| measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD | — |
| markers | — |
| Secondary variables are: Total Body Composition & Total Body Calcium (TBC), | — |
Countries
United States
Outcome results
None listed