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

NCT02509767 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2019-09-18

Study results available
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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.

Conditions

  • Contraception

Interventions

DRUG

Subcutaneous depot medroxyprogesterone acetate

Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Tara Health Foundation

    collaborator UNKNOWN

  • Planned Parenthood Federation of America

    lead OTHER

Principal Investigators

  • Julia E Kohn, PhD, MPA · Planned Parenthood Federation of America

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-04-30
Completion
2017-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02509767 on ClinicalTrials.gov