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Anti-progestational Steroid

Mifepristone for Pregnancy and Miscarriage

Phase 4
Waitlist Available
Research Sponsored by University of California, San Francisco
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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Study 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 weeks
Treatment ~ Varies
Follow Up ~day 14 following initial medication abortion visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 following initial medication abortion visit for reporting.

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 • NCT01990560
13%
Drug Rash
13%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mifepristone

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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

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?

University of California, San FranciscoLead Sponsor
2,481 Previous Clinical Trials
12,163,545 Total Patients Enrolled
Daniel Grossman, MDLead Sponsor

Media Library

Mifepristone (Anti-progestational Steroid) Clinical Trial Eligibility Overview. Trial Name: NCT03913104 — Phase 4
Pregnancy Research Study Groups: Medication Abortion Patients
Pregnancy Clinical Trial 2023: Mifepristone Highlights & Side Effects. Trial Name: NCT03913104 — Phase 4
Mifepristone (Anti-progestational Steroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03913104 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widely distributed is this clinical trial?

"To date, enrolment for this trial is taking place across a variety of locations such as Lifespan in Providence, Pennsylvania, Allegheny Reproductive Health Center in Pittsburgh and Planned Parenthood Rocky Mountains in Denver. Additionally, there are numerous other sites enrolling patients."

Answered by AI

What medical ailments is Mifepristone typically utilized to address?

"Mifepristone is an effective therapeutic agent for treating hyperglycemia, as well as medical procedures such as abortion."

Answered by AI

Are new participants being welcomed into this medical experiment?

"As reported on clinicaltrials.gov, this medical trial is inactive in terms of participant recruitment. First posted on May 1st 2020 and last updated July 8th 2022, there are no enrolment opportunities for prospective patients at the moment; however, 148 other trials remain open to participants."

Answered by AI

What is the current regulatory status of Mifepristone?

"Mifepristone has already been approved for use, so it is assigned a safety score of 3."

Answered by AI

What other research initiatives have been conducted on Mifepristone?

"Research into the efficacy of mifepristone began in 2016 at Integrated Program for Substance Abuse Research, and has since culminated in 85 trials. At present, 10 clinical studies are underway with a generous portion of these being conducted from Providence, Pennsylvania."

Answered by AI

How many participants have been accepted into the research initiative thus far?

"This study is no longer open for recruitment. It was first listed on the 5th of January 2020 and last updated on 8th July 2022. However, there are currently 138 studies concerning early abortion that require participants, with 10 trials dedicated to Mifepristone specifically searching for volunteers."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~106 spots leftby Feb 2025