Mail Order Mifepristone Study

• ClinicalTrials.gov Identifier: NCT03913104
• Recruitment Status: Recruiting
• First Posted: April 12, 2019
• Last Update Posted: February 2, 2022
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): Daniel Grossman, University of California, San Francisco

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Abortion Early; Pregnancy Related	Drug: Mifepristone	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 425 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective Cohort
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy
• Actual Study Start Date: January 5, 2020
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: January 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Sarah Raifman, MSc; 510-986-8970; sarah.raifman@ucsf.edu

Locations

United States, California

Highland Hospital; Recruiting

Oakland, California, United States, 94602

Contact: Stephanie Ho, MD

Principal Investigator: Stephanie Ho

Children's Hospital Oakland; Recruiting

Oakland, California, United States, 94609

Contact: Lela Bachrach, MD

Principal Investigator: Lela Bachrach, MD

United States, Colorado

Planned Parenthood Rocky Mountains; Recruiting

Denver, Colorado, United States, 80218

Contact: Ann Firstenberg

Principal Investigator: Kristina Tocce, MD

United States, Delaware

Christiana Care Health System; Recruiting

Wilmington, Delaware, United States, 19899

Contact: Diana Wohler, MD

Principal Investigator: Diana Wohler, MD

United States, Georgia

Atlanta Comprehensive Wellness Clinic; Recruiting

Atlanta, Georgia, United States, 30324

Contact: Tamer Middleton, MD

United States, New York

Albert Einstein College of Medicine; Active, not recruiting

New York, New York, United States, 10461

Southern Tier Women's Health Services; Recruiting

Vestal, New York, United States, 13850

Contact: Susan Seibold-Simpson, PhD

Principal Investigator: Susan Seibold-Simpson, PhD

Principal Investigator: Amy Cousins, MD

United States, Pennsylvania

Delaware County Women's Center; Recruiting

Chester, Pennsylvania, United States, 19013

Contact: Curtiss Hannum, NP

Principal Investigator: Curtiss Hannum, NP

Allegheny Reproductive Health Center; Recruiting

Pittsburgh, Pennsylvania, United States, 15206

Contact: Grace Ferguson, MD

United States, Rhode Island

Brown Family Medicine; Recruiting

Pawtucket, Rhode Island, United States, 02860

Contact: Andrea Arena, MD

Principal Investigator: Andrea Arena, MD

Lifespan; Recruiting

Providence, Rhode Island, United States, 02905

Contact: Mindy Sobota, MD

Principal Investigator: Mindy Sobota, MD

Sponsors and Collaborators

University of California, San Francisco

Investigators

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

More Information

• Responsible Party: Daniel Grossman, Professor and Director of ANSIRH, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03913104
• Other Study ID Numbers: 18-26819
• First Posted: April 12, 2019
• Last Update Posted: February 2, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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