Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators are doing this study to look at how different doses of the Depot medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens. The investigators hope that what the investigators learn from this study will be used to develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nationwide Children's Hospital
• Collaborator: Society of Family Planning
• Treatments: Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

Inclusion Criteria:

1. Age 12-21 years

2. Healthy, post-menarcheal female

3. Self-selected to initiate depot medroxyprogesterone acetate (DMPA)

4. Willingness to use a barrier method of contraception in addition to DMPA

Exclusion Criteria:

1. Chronic disease known to affect weight or bone mineral density (BMD) (e.g. diabetes, kidney)

2. Use of medication known to affect weight or BMD (e.g. corticosteroids)

3. DMPA use within the past 12 months

4. Pregnancy within the past 6 months

5. Etonogestrel implant, levonorgestrel-releasing intrauterine system or combined estrogen/progesterone contraceptive use within the past 30 days (OC, patch, vaginal ring)

6. Weight exceeding 450 lbs

7. Need for confidential contraceptive care for individuals < 18 years of age.