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Mail Order Mifepristone Study
Phase 4 trial testing Mifepristone in Abortion Early in 536 participants. Completed in 30 July 2023.
| Lead sponsor | Daniel Grossman, MD |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 536 |
| Start date | 5 January 2020 |
| Primary completion | 30 July 2023 |
| Estimated completion | 30 July 2023 |
| Sites | 11 locations across United States |
Daniel Grossman, MD
15 and older, female only, with Abortion Early or Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance.
| Group | Value | 95% CI |
|---|---|---|
| Medication Abortion Patients | 452 | |
| Medication Abortion Patients | 26 | |
| Medication Abortion Patients | 7 | |
| Medication Abortion Patients | 4 |
Percentage of participants reporting they would prefer to receive medications by mail for future medication abortion, by abortion instance.
| Group | Value | 95% CI |
|---|---|---|
| Medication Abortion Patients | 431 | |
| Medication Abortion Patients | 20 | |
| Medication Abortion Patients | 26 |
Percentage of participants who received the medications by mail-order pharmacy by Day 2 and Day 3, by abortion instance.
| Group | Value | 95% CI |
|---|---|---|
| Medication Abortion Patients | 381 |
| Group | Value | 95% CI |
|---|---|---|
| Medication Abortion Patients | 436 |
Percentage of participants who reported that confidentiality was maintained when they received the medications by mail-order pharmacy, by abortion instance.
| Group | Value | 95% CI |
|---|---|---|
| Medication Abortion Patients | 486 | |
| Medication Abortion Patients | 8 | |
| Medication Abortion Patients | 1 |
Percentage of participants who experienced a complete medication abortion, by abortion instance.
| Group | Value | 95% CI |
|---|---|---|
| Medication Abortion Patients | 499 | |
| Medication Abortion Patients | 5 | |
| Medication Abortion Patients | 6 |
Percentage of participants who experience adverse events related to the abortion, by abortion instance.
| Group | Value | 95% CI |
|---|---|---|
| Medication Abortion Patients | 21 |
| Group | Value | 95% CI |
|---|---|---|
| Medication Abortion Patients | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Medication Abortion Patients | 0 |
Provider acceptability will be assessed qualitatively through open-ended interviews with providers and staff involved in the study.
| Group | Value | 95% CI |
|---|---|---|
| Staff and Clinicians Involved in Mail-order Dispensing at Study Sites | 24 |
Time frame: Follow-up data were collected among participants up to six weeks after initial medication abortion visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Medication Abortion Patients |
|---|---|---|
| Hospitalization | Reproductive system and breast disorders | — |
| Hemorrhage requiring blood transfusion | Reproductive system and breast disorders | — |
| Reaction | System | Medication Abortion Patients |
|---|---|---|
| Bleeding | Reproductive system and breast disorders | — |
| Pain | Reproductive system and breast disorders | — |
| Nausea/vomiting | General disorders | — |
| Infection | Reproductive system and breast disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Incomplete abortion | Surgical and medical procedures | — |
| Dehydration | General disorders | — |
| Vaginitis | Reproductive system and breast disorders | — |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Hospitalization, Hemorrhage requiring blood transfusion.
Data from ClinicalTrials.gov NCT03913104 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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