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Patient Agreement Form and Medication Abortion Knowledge

NCT07604675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 637

Last updated 2026-05-22

No results posted yet for this study

Summary

This study evaluates whether exposure to the U.S. Food and Drug Administration (FDA)-required Patient Agreement Form (PAF) for mifepristone improves patient knowledge about medication abortion. Participants seeking medication abortion at clinical sites in the United States were randomized to complete a knowledge assessment either before or after reviewing and signing the PAF. The primary objective was to assess whether exposure to the PAF improves knowledge related to medication abortion, including medication use, effectiveness, risks, and when to seek medical care.

Conditions

  • Medication Abortion
  • Health Knowledge Attitudes and Practice
  • Pregnant People

Interventions

BEHAVIORAL

Patient Agreement Form (PAF)

The Patient Agreement Form is a document required under the FDA Risk Evaluation and Mitigation Strategy (REMS) program for mifepristone. It includes information about medication abortion, including risks, side effects, and instructions for use, and must be reviewed and signed by patients prior to receiving the medication.

Sponsors & Collaborators

Principal Investigators

  • Daniel Grossman, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2025-10-17
Completion
2025-10-17

Countries

  • United States

Study Locations

More Related Trials

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 NCT07604675 on ClinicalTrials.gov