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Anti-progestational Steroid
Mifepristone for Pregnancy and Miscarriage
Phase 4
Waitlist Available
Research Sponsored by Daniel Grossman, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14 following initial medication abortion visit
Awards & highlights
Summary
This trial will test if it's feasible to mail abortion medication to patients, who will then take it at home.
Eligible Conditions
- Pregnancy
- Miscarriage
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 14 following initial medication abortion visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14 following initial medication abortion visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients who report positive experience.
Secondary outcome measures
Proportion of patients who have a complete abortion
Proportion of patients who report timely delivery of medication.
Side effects data
From 2016 Phase 4 trial • 8 Patients • NCT0199056013%
Drug Rash
13%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mifepristone
Trial Design
1Treatment groups
Experimental Treatment
Group I: Medication Abortion PatientsExperimental Treatment1 Intervention
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mifepristone
2013
Completed Phase 4
~3080
Find a Location
Who is running the clinical trial?
Daniel Grossman, MDLead Sponsor
University of California, San FranciscoLead Sponsor
2,528 Previous Clinical Trials
15,242,094 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are willing and able to participate in the study, including willing and able to receive medications at home or other preferred address within 3 days of initial medication abortion visit.You do not want to have a medication-induced abortion.You cannot take medication to end a pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Medication Abortion Patients
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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