Mail Order Mifepristone Study

NCT03913104 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 18-26819
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 11

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.

Conditions

Abortion Early; Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3

  Day 3 following initial medication abortion visit

• Feasibility: Confidentiality Maintained When Receiving Medications by Mail

  Day 3 following initial medication abortion visit

• Clinical Effectiveness of Mail-Order Medication Abortion

  Up to 6 weeks after initial medication abortion visit.

• Clinical Safety of Mail-Order Medication Abortion

  Up to 6 weeks after initial medication abortion visit.

• Provider Acceptability of Mail-Order Dispensing of Medication Abortion

  Up to 3 months after data collection completed.

Study Arms (1)

Medication Abortion Patients

EXPERIMENTAL

Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)

Drug: Mifepristone

Interventions

Mifepristone DRUG

Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.

Medication Abortion Patients

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Daniel Grossman, MD: lead

Study Sites (11)

Highland Hospital

Oakland, California, 94602, United States

Location

Children's Hospital Oakland

Oakland, California, 94609, United States

Location

Planned Parenthood Rocky Mountains

Denver, Colorado, 80218, United States

Location

Christiana Care Health System

Wilmington, Delaware, 19899, United States

Location

Atlanta Comprehensive Wellness Clinic

Atlanta, Georgia, 30324, United States

Location

Albert Einstein College of Medicine

New York, New York, 10461, United States

Location

Southern Tier Women's Health Services

Vestal, New York, 13850, United States

Location

Delaware County Women's Center

Chester, Pennsylvania, 19013, United States

Location

Allegheny Reproductive Health Center

Pittsburgh, Pennsylvania, 15206, United States

Location

Brown Family Medicine

Pawtucket, Rhode Island, 02860, United States

Location

Lifespan

Providence, Rhode Island, 02905, United States

Location

Related Publications (2)

• Raifman S, Gurazada T, Beaman J, Biggs MA, Schwarz EB, Gold M, Grossman D. Primary care and abortion provider perspectives on mail-order medication abortion: a qualitative study. BMC Womens Health. 2024 Jul 3;24(1):382. doi: 10.1186/s12905-024-03202-z.

  PMID: 38956609 DERIVED

• 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.

  PMID: 34555420 DERIVED

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Lack of randomization may limit generalizability. Clinical sites that agreed to participate had at least 1 motivated clinician and a supportive administrative environment and were located in states with relatively few abortion restrictions. Study participants were open to mail-order dispensing, but this option may not be acceptable/feasible for all patients. The study was not powered to precisely estimate safety outcomes. Satisfaction may be overestimated due to social desirability bias.

Results Point of Contact

• Title: Natalie Morris
• Organization: University of California, San Francisco

natalie.morris@ucsf.edu

(415) 353-4724

Study Officials

• Daniel Grossman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Director of ANSIRH

Model Details: Prospective Cohort

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 12, 2019
• Study Start: January 5, 2020
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: August 14, 2024
• Results First Posted: August 14, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)