The Misoprostol-Only Regimen Evidence Study

NCT07174856 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 1394391
• Study Type: interventional
• Target: 1,900
• Locations: 1 country
• Sites: 1

Brief 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. 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:

• 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

Conditions

Abortion, Medical

Keywords

misoprostol; mifepristone; medication abortion

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Completion measured 28-42 days after taking the pills

Secondary Outcomes (1)

• hCG decline

  Change in beta hCG between 0 and 7-14 days post medication abortion

Study Arms (2)

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.

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.

Drug: Misoprostol-only medication abortion regimen

Interventions

Misoprostol-only medication abortion regimen DRUG

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.

Misoprostol-only

Combined regimen DRUG

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.

Combined regimen

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ibis Reproductive Health: lead
• University of Utah: collaborator
• Planned Parenthood Association of Utah: collaborator

Study Sites (1)

Planned Parenthood Association of Utah

Salt Lake City, Utah, 84102, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: At a minimum, we will make key components of the study protocol as well as a de-identified dataset with key data elements available to members of the scientific community within 6 months of publication of the primary and secondary study outcomes.
• Access Criteria: Interested researchers can contact the study team with a brief analysis plan and the research team will share the data with those researchers.

Locations

US (1)