Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This randomized clinical trial will study subcutaneous depot medroxyprogesterone acetate (DMPA sc) self-administration at two Planned Parenthood affiliates serving diverse patient populations. Prior studies demonstrate that DMPA self-injection is safe, effective, feasible, and acceptable for women and adolescents. A total of 400 female patients (ages 15-44) requesting DMPA will be randomized to self-administration of DMPA sc or clinic administration (usual care). Subjects will be followed for one year. The primary study outcome is DMPA continuation at one year by self-report in both study arms. Secondary outcomes include patient-reported satisfaction with treatment; satisfaction with home use; and costs associated with contraceptive care. The investigators hypothesize higher continuation rates among self-injection users compared to patients who receive standard care. Secondary exploratory hypotheses include higher patient satisfaction and lower costs associated with contraceptive care among self-injection users.

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

Details

• Lead Sponsor: Planned Parenthood Federation of America
• Collaborators: Pfizer; Tara Health Foundation
• Treatments: Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

Inclusion Criteria:

• Females ages 15-44

• Current or past users of DMPA or desires initiation of DMPA for contraception

• Can understand spoken and written English or Spanish

• Willing to consider/attempt DMPA self-injection

• Willing to be randomized to either self- or clinic administration of DMPA

• Do not want to become pregnant in the next 12 months

• Willing to provide contact information and to complete three surveys at baseline, 6 months, and 12 months

• Have consistent access to a working telephone, email, and Internet

• No contraindications to DMPA use

Exclusion Criteria:

• Suspected or confirmed pregnancy

• Vaginal bleeding of unknown etiology

• Known or suspected breast cancer

• Acute liver disease

• High blood pressure (Systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg)

• Known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA

• Desire for pregnancy within one year