Abortion, MedicalPhase 4MORENCT07174856
The Misoprostol-Only Regimen Evidence Study
A Phase 4 study testing Misoprostol-only medication abortion regimen and Combined regimen in people with Abortion, Medical, run by Ibis Reproductive Health at 1 site in United States.
Trial summary
The goal of this study is to evaluate the effectiveness, non-inferiority, and side-effect profile of an updated misoprostol-only regimen, as compared to the combined mifepristone-misoprostol regimen, among people seeking medication abortion (MAB) through 77 days of pregnancy in telehealth and in-person settings. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Abortion, Medical
- What is being tested?
- Misoprostol-only medication abortion regimen and Combined regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2025to Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnancy of < or = 77 days duration based on LMP or ultrasound
- Positive pregnancy test (self-report or in-clinic)
- Age: States without parental involvement laws : in-person patients ages 14 years and older; States with parental involvement or notification laws: 18 years or older
- Willing and able to give informed consent
- Willing to comply with study protocol
- Willing to record requested information in the study surveys
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- English or Spanish speaking
- Has a text message, email, or phone call capable device for survey completion
- Understands and signs an Institutional Review Board (IRB) approved informed consent form prior to undergoing any study procedures or randomization
Who cannot join
- concurrent participation in any other interventional trial
- unwilling to comply with the study protocol and survey/visit schedule
- contraindication to mifepristone (chronic corticosteroid administration, adrenal disease)
- contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin)
- cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)
- diagnosis of porphyria
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- known bleeding disorder or receiving anticoagulants
- pregnancy with an IUD in place
- diagnosis of pregnancy of unknown location (PUL), early pregnancy failure, incomplete or inevitable abortion (absent gestational sac and/or open cervical os)
- possibility of ectopic pregnancy
- known or suspected pelvic infection
- Have issues or concerns (in the judgement of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
- Have previously participated in the study
- Be a site staff member with delegated study responsibilities or a family member of, or have a close relationship with, a site staff member with delegated study responsibilities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Planned Parenthood Association of Utah
Salt Lake City, Utah, 84102
Director of Research, 885-355-1875, Priscila.Monteiro@ppau.org
Lori Gawron, MD
About this study
Official title: The Misoprostol-Only Regimen Evidence (MORE) Study: A Randomized Controlled Trial Comparing the Misoprostol-only Regimen Versus the Combined Mifepristone and Misoprostol Regimen for Medication Abortion
The goal of this study is to evaluate the effectiveness, non-inferiority, and side-effect profile of an updated misoprostol-only regimen, as compared to the combined mifepristone-misoprostol regimen, among people seeking medication abortion (MAB) through 77 days of pregnancy in telehealth and in-person settings. The investigators aim to evaluate this in both in-clinic and telehealth medication abortion care in the United States.
The main questions it aims to answer are:
Read more
- What proportion of pregnant people using an updated misoprostol-only medication abortion regimen have a complete abortion using just the prescribed pills?
- Is the updated misoprostol-only medication abortion regimen no more than 5% less effective (non-inferior) than the standard combined medication abortion regimen?
- What is the pattern of beta hCG decline following use of a misoprostol-only medication abortion through 77 days of pregnancy?
Participants will:
- be randomized to one of two medication regimens (misoprostol-only or the combined regimen) in a 1:1 ratio based on duration of pregnancy at enrollment. - self-report outcomes via daily surveys for the first 3 days, and thereafter weekly at 7, 14, 21, 28, and 35 days.
- return to the clinical site for tests as instructed
The investigators hypothesize that the proportion with complete abortions in the misoprostol-only arm will be non-inferior to the proportion with complete abortions in the combined regimen arm within a 5% margin of inferiority
Read the detailed description
This is a randomized controlled trial comparing misoprostol-only (3-4 doses x 800μg misoprostol sublingually every 3 hours) (Arm 2) to the combined regimen (<64 days: mifepristone (200mg orally) followed 24-48 hours later by misoprostol (800μg b/v) with a second dose of misoprostol (800μg b/v) taken 3 hours later only for those 64-77 days) (Arm 1). The combined regimen is the standard of care for medication abortion in the United States, and both regimens are widely used across the globe for termination of pregnancy. Participants will be randomized to each group in a 1:1 ratio based on duration of pregnancy at enrollment. The primary outcome is the proportion who have a complete abortion (no ongoing pregnancy) without procedural intervention or additional doses of medication as determined by negative HSPT between 28-42 days, ultrasound, or declining serum beta hCG by clinic protocols. Side effects, additional interventions, adverse events, acceptability, and quality of care will be assessed with daily surveys for the first 3 days, and thereafter weekly at 7, 14, 21, 28, and 35 days.
The primary outcome for this study is complete abortion, defined as successful expulsion of the intrauterine pregnancy without need for procedural intervention or additional doses of medication during the follow-up period as determined by negative HSPT between 28-42 days, ultrasound, or declining serum beta hCG by clinic protocols. The investigators will report abortion completion overall by study arm. Additionally, the investigators will evaluate and report on the non-inferiority of abortion completion following use of the misoprostol-only regimen as compared to the combined mifepristone and misoprostol regimen.
Participants will be determined to have had a complete abortion without need for procedural intervention or additional doses of medication, and the investigators will also report the number and proportion of complete abortions as defined more broadly by the MARE guidelines as successful expulsion of the intrauterine pregnancy without need for procedural intervention.
Secondary study endpoints include:
- change in serum beta hCG 7-14 days following use of the misoprostol-only regimen and in the mifepristone-misoprostol regimen
In more detail, secondary outcomes to be measured include declines in serum beta hCG between baseline and 7-14 days among a subset of participants to characterize patterns following use of the misoprostol-only regimen and the combined mifepristone-misoprostol regimen.
- Conditions
- Abortion, Medical
- Being tested
- Misoprostol-only medication abortion regimen, Combined regimen
- Keywords
- misoprostol, mifepristone, medication abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol-only medication abortion regimenDrug
This intervention is an updated misoprostol-only regimen that involves being counseled on and receiving medications for a medication abortion using 3-4 doses of 800μg misoprostol administered sublingually every 3 hours.
Combined regimenDrug
This intervention will involve participants being counseled on and receiving medications for a medication abortion regimen of mifepristone (200mg orally) followed 24-48 hours later by misoprostol (800μg b/v) with a second dose of misoprostol (800μg b/v) taken 3 hours later only for those 64-77 days.
| Study group | Role | What they receive |
|---|---|---|
| Combined regimen | Active comparator | Participants in this arm are randomized to receive the standard of care combined mifepristone + misoprostol regimen. Specifically, for those with pregnancies <64 days, mifepristone (200mg orally) followed 24-48 hours later by misoprostol (800μg b/v); for those 64-77 days, they will take a second dose of misoprostol (800μg b/v) taken 3 hours later. Receives: Drug: Combined regimen |
| Misoprostol-only | Experimental | Participants in this arm will be randomized to receive a misoprostol-only regimen. Specifically, 3-4 doses of 800μg misoprostol administered sublingually every 3 hours. Receives: Drug: Misoprostol-only medication abortion regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abortion completion
The primary outcome for this study is complete abortion, defined as successful expulsion of the intrauterine pregnancy without need for procedural intervention or additional doses of medication during the follow-up period as determined by negative HSPT, ultrasound, or declining serum beta hCG by clinic protocols.
Measured: 28-42 days after taking the pills
Non-inferiority of the misoprostol-only regimen
Study investigators will evaluate and report on the non-inferiority of abortion completion following use of the misoprostol-only regimen as compared to the combined mifepristone and misoprostol regimen within a 5% margin of inferiority.
Measured: Completion measured 28-42 days after taking the pills
Secondary outcomes (1)
hCG decline
We will measure declines in serum beta hCG between baseline and 7-14 days among a subset of participants to characterize patterns following use of the misoprostol-only regimen and the combined mifepristone-misoprostol regimen.
Measured: Change in beta hCG between 0 and 7-14 days post medication abortion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start10 Oct 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, MedicalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ibis Reproductive Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, Planned Parenthood Association of Utah
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174856
- Sponsor's protocol ID
- 1394391
- Acronym
- MORE
- Status last verified
- Oct 2025
- First submitted
- 9 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share a de-identified dataset that includes at a minimum: treatment group, adherence to treatment, and primary outcome (abortion completion).
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Misoprostol-Only Regimen Evidence (MORE) Study: A Randomized Controlled Trial Comparing the Misoprostol-only Regimen Versus the Combined Mifepristone and Misoprostol Regimen for Medication Abortion
- ClinicalTrials.gov ID
- NCT07174856
- Acronym / sponsor ID
- MORE / 1394391
- Conditions
- Abortion, Medical
- Keywords
- misoprostol, mifepristone, medication abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- Ibis Reproductive HealthUniversity, hospital or other
- Collaborators
- University of Utah, Planned Parenthood Association of Utah
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the effectiveness, non-inferiority, and side-effect profile of an updated misoprostol-only regimen, as compared to the combined mifepristone-misoprostol regimen, among people seeking medication abortion (MAB) through 77 days of pregnancy in telehealth and in-person settings. The investigators aim to evaluate this in both in-clinic and telehealth medication abortion care in the United States.
The main questions it aims to answer are:
- What proportion of pregnant people using an updated misoprostol-only medication abortion regimen have a complete abortion using just the prescribed pills?
- Is the updated misoprostol-only medication abortion regimen no more than 5% less effective (non-inferior) than the standard combined medication abortion regimen?
- What is the pattern of beta hCG decline following use of a misoprostol-only medication abortion through 77 days of pregnancy?
Participants will:
- be randomized to one of two medication regimens (misoprostol-only or the combined regimen) in a 1:1 ratio based on duration of pregnancy at enrollment. - self-report outcomes via daily surveys for the first 3 days, and thereafter weekly at 7, 14, 21, 28, and 35 days.
- return to the clinical site for tests as instructed
The investigators hypothesize that the proportion with complete abortions in the misoprostol-only arm will be non-inferior to the proportion with complete abortions in the combined regimen arm within a 5% margin of inferiority
Detailed description
This is a randomized controlled trial comparing misoprostol-only (3-4 doses x 800μg misoprostol sublingually every 3 hours) (Arm 2) to the combined regimen (<64 days: mifepristone (200mg orally) followed 24-48 hours later by misoprostol (800μg b/v) with a second dose of misoprostol (800μg b/v) taken 3 hours later only for those 64-77 days) (Arm 1). The combined regimen is the standard of care for medication abortion in the United States, and both regimens are widely used across the globe for termination of pregnancy. Participants will be randomized to each group in a 1:1 ratio based on duration of pregnancy at enrollment. The primary outcome is the proportion who have a complete abortion (no ongoing pregnancy) without procedural intervention or additional doses of medication as determined by negative HSPT between 28-42 days, ultrasound, or declining serum beta hCG by clinic protocols. Side effects, additional interventions, adverse events, acceptability, and quality of care will be assessed with daily surveys for the first 3 days, and thereafter weekly at 7, 14, 21, 28, and 35 days.
The primary outcome for this study is complete abortion, defined as successful expulsion of the intrauterine pregnancy without need for procedural intervention or additional doses of medication during the follow-up period as determined by negative HSPT between 28-42 days, ultrasound, or declining serum beta hCG by clinic protocols. The investigators will report abortion completion overall by study arm. Additionally, the investigators will evaluate and report on the non-inferiority of abortion completion following use of the misoprostol-only regimen as compared to the combined mifepristone and misoprostol regimen.
Participants will be determined to have had a complete abortion without need for procedural intervention or additional doses of medication, and the investigators will also report the number and proportion of complete abortions as defined more broadly by the MARE guidelines as successful expulsion of the intrauterine pregnancy without need for procedural intervention.
Secondary study endpoints include:
- change in serum beta hCG 7-14 days following use of the misoprostol-only regimen and in the mifepristone-misoprostol regimen
In more detail, secondary outcomes to be measured include declines in serum beta hCG between baseline and 7-14 days among a subset of participants to characterize patterns following use of the misoprostol-only regimen and the combined mifepristone-misoprostol regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined regimen | Active comparator | Drug: Combined regimenParticipants in this arm are randomized to receive the standard of care combined mifepristone + misoprostol regimen. Specifically, for those with pregnancies <64 days, mifepristone (200mg orally) followed 24-48 hours later by misoprostol (800μg b/v); for those 64-77 days, they will take a second dose of misoprostol (800μg b/v) taken 3 hours later. |
| Misoprostol-only | Experimental | Drug: Misoprostol-only medication abortion regimenParticipants in this arm will be randomized to receive a misoprostol-only regimen. Specifically, 3-4 doses of 800μg misoprostol administered sublingually every 3 hours. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Pregnancy of < or = 77 days duration based on LMP or ultrasound
- Positive pregnancy test (self-report or in-clinic)
- Age: States without parental involvement laws : in-person patients ages 14 years and older; States with parental involvement or notification laws: 18 years or older
- Willing and able to give informed consent
- Willing to comply with study protocol
Key exclusion criteria (14 listed)
- concurrent participation in any other interventional trial
- unwilling to comply with the study protocol and survey/visit schedule
- contraindication to mifepristone (chronic corticosteroid administration, adrenal disease)
- contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin)
- cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)
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 |
|---|---|---|
| Misoprostol-only medication abortion regimenThis intervention is an updated misoprostol-only regimen that involves being counseled on and receiving medications for a medication abortion using 3-4 doses of 800μg misoprostol administered sublingually every 3 hours. | Drug | Misoprostol-only |
| Combined regimenThis intervention will involve participants being counseled on and receiving medications for a medication abortion regimen of mifepristone (200mg orally) followed 24-48 hours later by misoprostol (800μg b/v) with a second dose of misoprostol (800μg b/v) taken 3 hours later only for those 64-77 days. | Drug | Combined regimen |
Primary outcome
Abortion completion
Time frame: 28-42 days after taking the pills
The primary outcome for this study is complete abortion, defined as successful expulsion of the intrauterine pregnancy without need for procedural intervention or additional doses of medication during the follow-up period as determined by negative HSPT, ultrasound, or declining serum beta hCG by clinic protocols.
Non-inferiority of the misoprostol-only regimen
Time frame: Completion measured 28-42 days after taking the pills
Study investigators will evaluate and report on the non-inferiority of abortion completion following use of the misoprostol-only regimen as compared to the combined mifepristone and misoprostol regimen within a 5% margin of inferiority.
1 secondary outcome
hCG decline
Time frame: Change in beta hCG between 0 and 7-14 days post medication abortion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: Yes. We will share a de-identified dataset that includes at a minimum: treatment group, adherence to treatment, and primary outcome (abortion completion).
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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.
Planned Parenthood Association of Utah
Salt Lake City, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol-only medication abortion regimen and Combined regimen in people with Abortion, Medical, run by Ibis Reproductive Health at 1 site 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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abortion completion (time frame: 28-42 days after taking the pills). 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?
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 8 Oct 2025.