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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Contraceptive Agents; Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

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