Trial Outcomes & Findings for Mail Order Mifepristone Study (NCT NCT03913104)
NCT ID: NCT03913104
Last Updated: 2024-08-14
Results Overview
Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
536 participants
Primary outcome timeframe
Day 14 following initial medication abortion visit
Results posted on
2024-08-14
Participant Flow
536 patients were consented and enrolled as part of this study. Four participants enrolled twice and were analyzed based on their abortion instance, leading to 540 abortions analyzed as part of this study.
Unit of analysis: Number of abortions
Participant milestones
| Measure |
Medication Abortion Patients
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
|
|---|---|
|
Overall Study
STARTED
|
536 540
|
|
Overall Study
Patient's Clinical Outcome Information Obtained
|
506 510
|
|
Overall Study
COMPLETED
|
506 510
|
|
Overall Study
NOT COMPLETED
|
30 30
|
Reasons for withdrawal
| Measure |
Medication Abortion Patients
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
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|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
|
Overall Study
Did Not Take Mifepristone or Misoprostol
|
8
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Mail Order Mifepristone Study
Baseline characteristics by cohort
| Measure |
Medication Abortion Patients
n=506 Participants
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
|
|---|---|
|
Age, Continuous
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27 years
n=506 Participants
|
|
Age, Customized
Age, Categorical · 15-19 years
|
30 Participants
n=506 Participants
|
|
Age, Customized
Age, Categorical · 20-24 years
|
144 Participants
n=506 Participants
|
|
Age, Customized
Age, Categorical · 25-29 years
|
161 Participants
n=506 Participants
|
|
Age, Customized
Age, Categorical · Greater than or equal to 30 years
|
171 Participants
n=506 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Black
|
194 Participants
n=506 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Hispanic
|
88 Participants
n=506 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · White
|
141 Participants
n=506 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Multiracial/other race
|
45 Participants
n=506 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Missing data
|
38 Participants
n=506 Participants
|
|
Region of Enrollment
United States
|
506 Participants
n=506 Participants
|
|
Educational level
High school or less
|
170 Participants
n=506 Participants
|
|
Educational level
Some college or professional school
|
206 Participants
n=506 Participants
|
|
Educational level
College or advanced degree
|
112 Participants
n=506 Participants
|
|
Educational level
Missing data
|
18 Participants
n=506 Participants
|
|
Parity
Nulliparous
|
189 Participants
n=506 Participants
|
|
Parity
Parous
|
317 Participants
n=506 Participants
|
|
Prior abortion experience
None
|
249 Participants
n=506 Participants
|
|
Prior abortion experience
Medication abortion
|
149 Participants
n=506 Participants
|
|
Prior abortion experience
Procedural abortion only
|
93 Participants
n=506 Participants
|
|
Prior abortion experience
Missing data
|
15 Participants
n=506 Participants
|
PRIMARY outcome
Timeframe: Day 14 following initial medication abortion visitPercentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance.
Outcome measures
| Measure |
Medication Abortion Patients
n=495 Number of abortions
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
|
|---|---|
|
Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion
Very satisfied
|
452 Number of abortions
|
|
Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion
Somewhat satisfied
|
26 Number of abortions
|
|
Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion
Neither satisfied nor dissatisfied
|
7 Number of abortions
|
|
Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion
Somewhat dissatisfied
|
4 Number of abortions
|
|
Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion
Very dissatisfied
|
6 Number of abortions
|
PRIMARY outcome
Timeframe: Day 14 following initial medication abortion visitPercentage of participants reporting they would prefer to receive medications by mail for future medication abortion, by abortion instance.
Outcome measures
| Measure |
Medication Abortion Patients
n=477 Number of abortions
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
|
|---|---|
|
Acceptability: Would Use Mail-Order Dispensing Again
Yes
|
431 Number of abortions
|
|
Acceptability: Would Use Mail-Order Dispensing Again
Not sure
|
26 Number of abortions
|
|
Acceptability: Would Use Mail-Order Dispensing Again
No
|
20 Number of abortions
|
SECONDARY outcome
Timeframe: Day 3 following initial medication abortion visitPercentage of participants who received the medications by mail-order pharmacy by Day 2 and Day 3, by abortion instance.
Outcome measures
| Measure |
Medication Abortion Patients
n=510 Number of abortions
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
|
|---|---|
|
Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3
Medications delivered by Day 2
|
381 Number of abortions
|
|
Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3
Medications delivered by Day 3
|
436 Number of abortions
|
SECONDARY outcome
Timeframe: Day 3 following initial medication abortion visitPercentage of participants who reported that confidentiality was maintained when they received the medications by mail-order pharmacy, by abortion instance.
Outcome measures
| Measure |
Medication Abortion Patients
n=495 Number of abortions
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
|
|---|---|
|
Feasibility: Confidentiality Maintained When Receiving Medications by Mail
Yes, confidentiality was maintained
|
486 Number of abortions
|
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Feasibility: Confidentiality Maintained When Receiving Medications by Mail
No, confidentiality was compromised
|
8 Number of abortions
|
|
Feasibility: Confidentiality Maintained When Receiving Medications by Mail
Missing data
|
1 Number of abortions
|
SECONDARY outcome
Timeframe: Up to 6 weeks after initial medication abortion visit.Percentage of participants who experienced a complete medication abortion, by abortion instance.
Outcome measures
| Measure |
Medication Abortion Patients
n=510 Number of abortions
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
|
|---|---|
|
Clinical Effectiveness of Mail-Order Medication Abortion
Abortion complete with medications only
|
499 Number of abortions
|
|
Clinical Effectiveness of Mail-Order Medication Abortion
Incomplete abortion
|
5 Number of abortions
|
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Clinical Effectiveness of Mail-Order Medication Abortion
Ongoing pregnancy
|
6 Number of abortions
|
SECONDARY outcome
Timeframe: Up to 6 weeks after initial medication abortion visit.Percentage of participants who experience adverse events related to the abortion, by abortion instance.
Outcome measures
| Measure |
Medication Abortion Patients
n=510 Number of abortions
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
|
|---|---|
|
Clinical Safety of Mail-Order Medication Abortion
Serious Adverse Event Related to Medication Abortion
|
3 Number of abortions
|
|
Clinical Safety of Mail-Order Medication Abortion
Adverse Event Related to Mail-Order Dispensing
|
0 Number of abortions
|
|
Clinical Safety of Mail-Order Medication Abortion
Adverse Event Related to Medication Abortion
|
21 Number of abortions
|
SECONDARY outcome
Timeframe: Up to 3 months after data collection completed.Population: Clinicians and staff involved in implementing a mail-order dispensing model for medication abortion were invited to complete qualitative interviews to share their experiences with non-in-person dispensing of mifepristone. These clinicians and staff were not officially enrolled as participants in the study, but rather contributed perspectives as clinic employees on the feasibility and acceptability of such a model.
Provider acceptability will be assessed qualitatively through open-ended interviews with providers and staff involved in the study.
Outcome measures
| Measure |
Medication Abortion Patients
n=24 Participants
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
|
|---|---|
|
Provider Acceptability of Mail-Order Dispensing of Medication Abortion
|
24 participants
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Adverse Events
Medication Abortion Patients
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Medication Abortion Patients
n=510 participants at risk
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
|
|---|---|
|
Reproductive system and breast disorders
Hemorrhage requiring blood transfusion
|
0.20%
1/510 • Number of events 1 • Follow-up data were collected among participants up to six weeks after initial medication abortion visit.
Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.
|
|
Reproductive system and breast disorders
Hospitalization
|
0.59%
3/510 • Number of events 3 • Follow-up data were collected among participants up to six weeks after initial medication abortion visit.
Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.
|
Other adverse events
| Measure |
Medication Abortion Patients
n=510 participants at risk
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
|
|---|---|
|
General disorders
Nausea/vomiting
|
0.59%
3/510 • Number of events 3 • Follow-up data were collected among participants up to six weeks after initial medication abortion visit.
Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.
|
|
Reproductive system and breast disorders
Infection
|
0.39%
2/510 • Number of events 2 • Follow-up data were collected among participants up to six weeks after initial medication abortion visit.
Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.
|
|
Gastrointestinal disorders
Diarrhea
|
0.39%
2/510 • Number of events 2 • Follow-up data were collected among participants up to six weeks after initial medication abortion visit.
Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.
|
|
Surgical and medical procedures
Incomplete abortion
|
0.39%
2/510 • Number of events 2 • Follow-up data were collected among participants up to six weeks after initial medication abortion visit.
Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.
|
|
General disorders
Dehydration
|
0.20%
1/510 • Number of events 1 • Follow-up data were collected among participants up to six weeks after initial medication abortion visit.
Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.
|
|
Reproductive system and breast disorders
Vaginitis
|
0.20%
1/510 • Number of events 1 • Follow-up data were collected among participants up to six weeks after initial medication abortion visit.
Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.20%
1/510 • Number of events 1 • Follow-up data were collected among participants up to six weeks after initial medication abortion visit.
Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.
|
|
Reproductive system and breast disorders
Bleeding
|
1.8%
9/510 • Number of events 9 • Follow-up data were collected among participants up to six weeks after initial medication abortion visit.
Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.
|
|
Reproductive system and breast disorders
Pain
|
1.8%
9/510 • Number of events 9 • Follow-up data were collected among participants up to six weeks after initial medication abortion visit.
Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.
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Additional Information
Natalie Morris
University of California, San Francisco
Phone: (415) 353-4724
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place