Mail Order Mifepristone Study

March 5, 2024 updated by: Daniel Grossman, MD

Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy

This study aims to evaluate the feasibility, acceptability, and effectiveness of dispensing mifepristone via a mail-order pharmacy. The investigators will recruit patients at up to 10 primary care and internal medicines sites not currently providing abortion services around the country, as well as abortion clinic sites. Patients will go through routine in clinic visits to determine eligibility and then will receive the medications in the mail at their preferred address. The investigators will survey patients 3 and 14 days after the initial clinic visit and interview providers at the end of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective cohort study of patients obtaining medication abortion via mifepristone dispensed from an online mail order pharmacy. After an initial pilot test with 25 patients, the investigators will identify 10 clinics to participate in the study. The study team will train primary care providers not currently providing abortion to provide medication abortion with the medications dispensed via mail order pharmacy. The investigators aim to recruit up to 650 patients for this study across all the sites. Patients will come in for an initial consult visit at the study site and then receive their medications at a preferred address within 3 days of the initial visit. Study participants will fill out surveys about their experience and feedback about the acceptability of the process; this will occur at 3 and 14 days after the initial recruitment visit. The investigators will also collect clinic data from patients and clinic sites to track clinical outcomes. And the investigators will interview providers at the end of the study to better understand their experiences prescribing mifepristone via mail-order.

Study Type

Interventional

Enrollment (Actual)

538

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94609
        • Children's Hospital Oakland
      • Oakland, California, United States, 94602
        • Highland Hospital
    • Colorado
      • Denver, Colorado, United States, 80218
        • Planned Parenthood Rocky Mountains
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • Christiana Care Health System
    • Georgia
      • Atlanta, Georgia, United States, 30324
        • Atlanta Comprehensive Wellness Clinic
    • New York
      • New York, New York, United States, 10461
        • Albert Einstein College of Medicine
      • Vestal, New York, United States, 13850
        • Southern Tier Women's Health Services
    • Pennsylvania
      • Chester, Pennsylvania, United States, 19013
        • Delaware County Women's Center
      • Pittsburgh, Pennsylvania, United States, 15206
        • Allegheny Reproductive Health Center
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Brown Family Medicine
      • Providence, Rhode Island, United States, 02905
        • Lifespan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women seeking medication abortion through 63 days gestation
  • Eligible for MifeprexⓇ at a study site
  • English or Spanish speaking
  • Willing and able to participate in the study, including willing and able to receive medications at home or other preferred address within 3 days of initial medication abortion visit

Exclusion Criteria:

  • Not pregnant
  • Not seeking medication abortion
  • under the age of 15
  • Over 63 days gestation
  • Contraindicated for medication abortion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medication Abortion Patients
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone)
Drug: Mifepristone
Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who report positive experience.
Time Frame: Day 14 following initial medication abortion visit
Proportion of patients reporting whether they would use the mail order service again if they needed another abortion.
Day 14 following initial medication abortion visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who report timely delivery of medication.
Time Frame: Day 3 following initial medication abortion visit
Proportion of patients who receive medications by Day 2 and Day 3 and proportion of patients who indicate their confidentiality was maintained when receiving medications by mail. The investigators will also estimate the proportion of patients who report that medications were lost, stolen or damaged.
Day 3 following initial medication abortion visit
Proportion of patients who have a complete abortion
Time Frame: Up to 6 weeks after initial medication abortion visit.
Using electronic health record data related to abortion, the investigators will estimate the proportion of patients who experience a complete abortion and the proportion of patients who experience complications, including adverse or severe adverse events.
Up to 6 weeks after initial medication abortion visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel Grossman, MD

Investigators

  • Principal Investigator: Daniel Grossman, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-26819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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