Phase 4
N=536
Mail Order Mifepristone Study
Abortion Early · Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT03913104 ↗Enrolled (actual)
536
Serious AEs
0.6%
Results posted
Aug 2024
Primary outcome: Primary: Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion — 452; 26; 7; 4 Number of abortions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mifepristone (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- Female
- Sponsor
- Daniel Grossman, MD
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion |
452; 26; 7; 4; 6 | — |
| PRIMARY Acceptability: Would Use Mail-Order Dispensing Again |
431; 20; 26 | — |
| SECONDARY Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3 |
381; 436 | — |
| SECONDARY Feasibility: Confidentiality Maintained When Receiving Medications by Mail |
486; 8; 1 | — |
| SECONDARY Clinical Effectiveness of Mail-Order Medication Abortion |
499; 5; 6 | — |
| SECONDARY Clinical Safety of Mail-Order Medication Abortion |
21; 3; 0 | — |
| SECONDARY Provider Acceptability of Mail-Order Dispensing of Medication Abortion |
24 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03913104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.