Misoprostol for Medical Abortion

(MORE Trial)

Age: Any Age

Sex: Female

Trial Phase: Phase 4

Sponsor: Ibis Reproductive Health

Must not be taking: Corticosteroids, Anticoagulants

Disqualifiers: Cardiovascular disease, Porphyria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate upon enrollment

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new misoprostol-only regimen for medication abortion compared to the standard combination of mifepristone and misoprostol. The study aims to determine if the misoprostol-only method is nearly as effective (within 5% less effective) and to identify any side effects. It is open to individuals up to 77 days pregnant and accommodates both in-person and telehealth participation. Participants will be divided into two groups to test either the new misoprostol method or the standard combination treatment and will report their outcomes through surveys. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for a broader patient population.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have certain health conditions or are taking specific medications like corticosteroids or anticoagulants, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that using only misoprostol for medication abortion is generally safe but less effective than using both mifepristone and misoprostol together. One study found that about 78% of individuals who used only misoprostol had a complete abortion without needing additional procedures or medications. Another study reported that most participants experienced a complete abortion with follow-up care.

Although using only misoprostol is less effective than the combined method, it remains safe for most patients. Prospective trial participants should know that misoprostol has been widely used and is generally well-tolerated. However, the likelihood of needing additional treatment is higher with misoprostol alone compared to using both medications. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for medical abortion because they offer more flexibility and could potentially increase access. The combined regimen uses both mifepristone and misoprostol, which is already the standard of care, but the trial is testing its effectiveness in a wider range of pregnancy durations. Meanwhile, the misoprostol-only regimen could be significant because it uses just one medication, which might be easier to distribute and administer, especially in areas with limited access to mifepristone. This focus on improving access and adaptability in medical abortion treatments is what makes these approaches particularly interesting.

What evidence suggests that this trial's treatments could be effective for medication abortion?

Research shows that using only misoprostol for medication abortion works well in many cases. A review of studies found it effective 84% to 96% of the time for pregnancies up to 63 days. Another study in the U.S. showed an 88% success rate. In this trial, one group of participants will receive a misoprostol-only regimen. However, evidence suggests that using both mifepristone and misoprostol together is generally more effective, with about a 95% success rate. Another group in this trial will receive the combined regimen. Despite this, using only misoprostol still results in a complete abortion in most cases. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals seeking medication abortion within 77 days of pregnancy, who can participate in daily and weekly surveys post-treatment, and return to the clinic for tests. Specific eligibility criteria are not provided.

Inclusion Criteria

Positive pregnancy test (self-report or in-clinic)

I am at least 14 years old and live in a state without parental consent laws, or I am 18 or older.

Pregnancy of ≤ 77 days duration based on LMP or ultrasound

Exclusion Criteria

Concurrent participation in any other interventional trial

Pregnancy with an IUD in place

Possibility of ectopic pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the misoprostol-only regimen or the combined mifepristone and misoprostol regimen for medication abortion

Immediate upon enrollment

1 visit (in-person or virtual)

Follow-up

Participants self-report outcomes via daily surveys for the first 3 days, and weekly at 7, 14, 21, 28, and 35 days. Complete abortion is assessed between 28-42 days

6 weeks

Multiple virtual check-ins

Long-term follow-up

Participants are monitored for changes in serum beta hCG and other secondary outcomes

7-14 days post medication abortion

What Are the Treatments Tested in This Trial?

Interventions

• Combined regimen
• Misoprostol-only medication abortion regimen

Trial Overview The study compares an updated misoprostol-only regimen against the standard combined mifepristone-misoprostol regimen for medical abortions. Participants will be randomly assigned to one of these two treatments and monitored through telehealth or in-person visits.

How Is the Trial Designed?

Group I: Misoprostol-only Experimental Treatment 1 Intervention

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.

Group II: Combined regimen Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Ibis Reproductive Health

Lead Sponsor

Trials

7

Recruited

8,400+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Planned Parenthood Association of Utah

Collaborator

Trials

1

Recruited

790+

Citations

1. evidence.nejm.org evidence.nejm.org/doi/full/10.1056/EVIDccon2300129

How Effective Is Misoprostol Alone for Medication Abortion? The often cited approximately 78% effectiveness of the misoprostol-only regimen comes from a seminal 2019 systematic review that pooled outcomes ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6309472/

Efficacy of Misoprostol Alone for First-Trimester Medical ... A systematic review published in 2007 found that the efficacy of misoprostol single-agent regimens at gestational ages ≤63 days ranged from 84% to 96%, but ...

3. ibisreproductivehealth.org ibisreproductivehealth.org/misoprostol-only-resource-hub

Misoprostol-only resource hub Findings from the first study on self-managed abortion with misoprostol only in the United States reflect this data, with 88% overall effectiveness and 97.8% ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811114

Medication Abortion Safety and Effectiveness With ... Clinical evidence has suggested that misoprostol alone is less effective than the combined regimen (approximately 80% vs approximately 95%), and ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010782423001981

Clinical outcomes of medication abortion using misoprostol ... Medication abortion with misoprostol-only was safe and produced complete abortion in most patients with follow-up.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37390948/

Clinical outcomes of medication abortion using misoprostol ... Medication abortion with misoprostol-only was safe and produced complete abortion in most patients with follow-up.

7. societyfp.org societyfp.org/wp-content/uploads/2023/05/Medication-abortion-with-misoprostol-only_A-sample-protocol_2023_Final.pdf

Medication abortion with misoprostol-only: A sample protocol Of the 12,829 patients who provided outcome data, 78% aborted completely without a procedure or unplanned additional medica- tions, a substantially lower ...