Phase 4
Completed N=401
Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
Source: ClinicalTrials.gov NCT02509767 ↗Enrolled (actual)
401
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms — 108; 85 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms |
108; 85 | — |
| SECONDARY Number of Participants Who Were Satisfied With Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in Both the Self- and Clinic Administration Arms |
147; 137 | — |
| SECONDARY Number of Participants Who Were Satisfied With Home Use of Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in the Self-Administration Arm |
137 | — |
| SECONDARY Costs Associated With Contraceptive Care |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02509767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.