Abortion EarlyPhase 4NCT03913104
Mail Order Mifepristone Study
A Phase 4 study testing Mifepristone in people with Abortion Early and Pregnancy Related, run by Daniel Grossman, MD at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion Early, Pregnancy Related
- What is being tested?
- Mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 11 sitesUnited States
- Study dates
- 5 Jan 2020to 30 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not pregnant
- Not seeking medication abortion
- under the age of 15
- Over 63 days gestation
- Contraindicated for medication abortion
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Atlanta Comprehensive Wellness Clinic
Atlanta, Georgia, 30324
Delaware County Women's Center
Chester, Pennsylvania, 19013
Planned Parenthood Rocky Mountains
Denver, Colorado, 80218
Albert Einstein College of Medicine
New York, New York, 10461
Highland Hospital
Oakland, California, 94602
Children's Hospital Oakland
Oakland, California, 94609
Brown Family Medicine
Pawtucket, Rhode Island, 02860
Allegheny Reproductive Health Center
Pittsburgh, Pennsylvania, 15206
Lifespan
Providence, Rhode Island, 02905
Southern Tier Women's Health Services
Vestal, New York, 13850
Christiana Care Health System
Wilmington, Delaware, 19899
About this study
Official title: Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy
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.
Read the 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
- Being tested
- Mifepristone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
| Study group | Role | What they receive |
|---|---|---|
| Medication Abortion Patients | Experimental | Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) Receives: Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 14 following initial medication abortion visit
Secondary outcomes (5)
Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3
Percentage of participants who received the medications by mail-order pharmacy by Day 2 and Day 3, by abortion instance.
Measured: Day 3 following initial medication abortion visit
Feasibility: Confidentiality Maintained When Receiving Medications by Mail
Percentage of participants who reported that confidentiality was maintained when they received the medications by mail-order pharmacy, by abortion instance.
Measured: Day 3 following initial medication abortion visit
Clinical Effectiveness of Mail-Order Medication Abortion
Percentage of participants who experienced a complete medication abortion, by abortion instance.
Measured: Up to 6 weeks after initial medication abortion visit.
Clinical Safety of Mail-Order Medication Abortion
Percentage of participants who experience adverse events related to the abortion, by abortion instance.
Measured: Up to 6 weeks after initial medication abortion visit.
Provider Acceptability of Mail-Order Dispensing of Medication Abortion
Provider acceptability will be assessed qualitatively through open-ended interviews with providers and staff involved in the study.
Measured: Up to 3 months after data collection completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start5 Jan 2020
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abortion EarlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Cohort
- Masking
- None (open label)
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Grossman, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Grossman, MD, University of California, San Francisco
- Investigators
- Daniel Grossman, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913104
- Sponsor's protocol ID
- 18-26819
- Status last verified
- Jul 2024
- First submitted
- 3 Apr 2019
- Last updated
- 14 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38956609Grossman 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.
PubMed 34555420
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy
- ClinicalTrials.gov ID
- NCT03913104
- Acronym / sponsor ID
- 18-26819
- Conditions
- Abortion Early, Pregnancy Related
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Daniel Grossman, MDUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Posted 14 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Cohort
| Arm | Type | Receives |
|---|---|---|
| Medication Abortion Patients | Experimental | Drug: MifepristoneOral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Not pregnant
- Not seeking medication abortion
- under the age of 15
- Over 63 days gestation
- Contraindicated for medication abortion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MifepristonePatients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit. | Drug | Medication Abortion Patients |
Primary outcome
Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion
Time frame: Day 14 following initial medication abortion visit
Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance.
Acceptability: Would Use Mail-Order Dispensing Again
Time frame: Day 14 following initial medication abortion visit
Percentage of participants reporting they would prefer to receive medications by mail for future medication abortion, by abortion instance.
5 secondary outcomes
Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3
Time frame: Day 3 following initial medication abortion visit
Feasibility: Confidentiality Maintained When Receiving Medications by Mail
Time frame: Day 3 following initial medication abortion visit
Clinical Effectiveness of Mail-Order Medication Abortion
Time frame: Up to 6 weeks after initial medication abortion visit.
Clinical Safety of Mail-Order Medication Abortion
Time frame: Up to 6 weeks after initial medication abortion visit.
Provider Acceptability of Mail-Order Dispensing of Medication Abortion
Time frame: Up to 3 months after data collection completed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38956609Raifman 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.
- Derived from this study: PubMed 34555420Grossman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Grossman, MD principal investigator
University of California, San Francisco
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mifepristone in people with Abortion Early and Pregnancy Related, run by Daniel Grossman, MD at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion (time frame: Day 14 following initial medication abortion visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03913104, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.