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New study tests simpler abortion pill regimen for early pregnancy

NCT ID NCT07174856

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,900 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

14 years and older

Sex

Female participants only

Healthy volunteers

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

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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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Planned Parenthood Association of Utah

    Salt Lake City, Utah, 84102, United States

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