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

Completed · Phase 4

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT02509767

Run by

Planned Parenthood Federation of America

People needed

401

Starts

2015-08-01

Expected to finish

2017-12-01

Last updated by the study team

2019-09-18

Who can join

Age: 15 and older, up to 44. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Planned Parenthood of Central and Greater Northern New Jersey — Morristown, New Jersey, United States
• Planned Parenthood Gulf Coast — Houston, Texas, United States

Full record on ClinicalTrials.gov

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