NCT03913104

Mail Order Mifepristone Study

Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 536 (actual)
• Sponsor: Daniel Grossman, MD · Academic / Other
• Sex: Female
• Age: 15 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Abortion Early
• Pregnancy Related

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-05
• Primary completion: 2023-07-30
• Completion: 2023-07-30
• First posted: 2019-04-12
• Last updated: 2024-08-14
• Results posted: 2024-08-14

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study