Mail Order Mifepristone Study

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: Pregnancy Related; Abortion Early
• Intervention / Treatment: Drug: Mifepristone

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): 536
• Phase: Phase 4

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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
Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion	Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance.	Day 14 following initial medication abortion visit
Acceptability: Would Use Mail-Order Dispensing Again	Percentage of participants reporting they would prefer to receive medications by mail for future medication abortion, by abortion instance.	Day 14 following initial medication abortion visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3	Percentage of participants who received the medications by mail-order pharmacy by Day 2 and Day 3, by abortion instance.	Day 3 following initial medication abortion visit
Feasibility: Confidentiality Maintained When Receiving Medications by Mail	Percentage of participants who reported that confidentiality was maintained when they received the medications by mail-order pharmacy, by abortion instance.	Day 3 following initial medication abortion visit
Clinical Effectiveness of Mail-Order Medication Abortion	Percentage of participants who experienced a complete medication abortion, by abortion instance.	Up to 6 weeks after initial medication abortion visit.
Clinical Safety of Mail-Order Medication Abortion	Percentage of participants who experience adverse events related to the abortion, by abortion instance.	Up to 6 weeks after initial medication abortion visit.
Provider Acceptability of Mail-Order Dispensing of Medication Abortion	Provider acceptability will be assessed qualitatively through open-ended interviews with providers and staff involved in the study.	Up to 3 months after data collection completed.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Grossman D, Raifman S, Morris N, Arena A, Bachrach L, Beaman J, Biggs MA, Hannum C, Ho S, Schwarz EB, Gold M. Mail-order pharmacy dispensing of mifepristone for medication abortion after in-person clinical assessment. Contraception. 2022 Mar;107:36-41. doi: 10.1016/j.contraception.2021.09.008. Epub 2021 Sep 20.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2020
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): July 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): August 14, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Mifepristone
• 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