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New study tests simpler abortion pill regimen for early pregnancy
NCT ID NCT07174856
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a misoprostol-only medication abortion regimen to the standard combined mifepristone and misoprostol regimen in people up to 77 days pregnant. About 1,900 participants will be randomly assigned to one of the two regimens and followed for up to 35 days. The goal is to see if the misoprostol-only regimen is as effective at completing the abortion without needing additional procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- misoprostol
- What this could lead to
- If successful, this could offer a simpler, more accessible medication abortion option using only misoprostol, potentially expanding access.
- What could go wrong
- This is a Phase 4 trial, but the misoprostol-only regimen may be less effective than the standard combined regimen, and side effects could differ.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 1,900 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Planned Parenthood Association of Utah
Salt Lake City, Utah, 84102, United States
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