← Back to Search

Antiprogestin

Mifepristone + Misoprostol for Abortion

Phase 3
Recruiting
Research Sponsored by Planned Parenthood League of Massachusetts
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial studies if two doses of at-home misoprostol is more successful than one dose for medication abortions with a pregnancy of unknown location.

Who is the study for?
This trial is for English-speaking individuals with a positive pregnancy test, no visible gestational sac on ultrasound, and no signs of ectopic pregnancy. They must want medication abortion and meet Planned Parenthood League of Massachusetts (PPLM) guidelines. Excluded are those under 18, unable to consent or follow the study plan, with certain medical conditions or allergies to the drugs used.
What is being tested?
The study tests if taking two doses of Misoprostol at home after Mifepristone increases the rate of completed abortions in cases where early pregnancy isn't visible on an ultrasound. Participants will be randomly assigned to receive either one or two doses of Misoprostol following Mifepristone.
What are the potential side effects?
Possible side effects include cramping, bleeding more than usual menstrual periods, nausea, vomiting, diarrhea, headache and dizziness. There's also a risk that the medications might not end an ectopic pregnancy if present.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of second dose of misoprostol
Recruitment rates, to determine feasibility of recruitment
Refusal rates, to determine feasibility of recruitment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mifepristone plus two doses misoprostolExperimental Treatment1 Intervention
Participant will take mifepristone, then at home will take two doses of misoprostol 4 hours apart to pass the pregnancy.
Group II: Mifepristone plus Single dose misoprostolActive Control1 Intervention
Participant will take mifepristone, then one dose of misoprostol at home to pass the pregnancy (current routine abortion care).

Find a Location

Who is running the clinical trial?

Planned Parenthood League of MassachusettsLead Sponsor
18 Previous Clinical Trials
14,997 Total Patients Enrolled
~23 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top