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Prostaglandin E1 Analog

Ulipristal Acetate Tablets for Miscarriage

Phase 2
Waitlist Available
Led By Jill M Hagey, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
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 from admission until day 30 follow up, +/- 7 days
Awards & highlights

Study Summary

This trial will study if using ulipristal acetate with misoprostol is an effective and safe way to treat early pregnancy loss.

Eligible Conditions
  • Miscarriage
  • Blighted Ovum

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from admission until day 30 follow up, +/- 7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from admission until day 30 follow up, +/- 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Adherent to Study Protocol
Percentage of Participants Recruited to Study Protocol
Percentage of Participants Retained in Study Protocol
Secondary outcome measures
Median Acceptability of Study Intervention
Number of Participants With Resolution of Early Pregnancy Loss Following Study Intervention
Number of Participants With Treatment-Related Adverse Events
+1 more
Other outcome measures
Number of Participants Needing Additional Medication for Resolution of Early Pregnancy Loss
Number of Participants Needing Surgical Management for Resolution of Early Pregnancy Loss

Side effects data

From 2023 Phase 2 trial • 3 Patients • NCT05216952
67%
Dizziness
67%
Fatigue
33%
Vaginal Bleeding Requiring Hospitalization
33%
Chills
33%
Severe cramping
33%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ulipristal Acetate (UPA) 90 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: UPA 90mgExperimental Treatment2 Interventions
Participants receive ulipristal acetate 90mg PO followed by self-administration of misoprostol 800mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ulipristal Acetate Tablets
2022
Completed Phase 2
~10
Misoprostol Pill
2022
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

North Carolina Translational and Clinical Sciences InstituteOTHER
57 Previous Clinical Trials
4,360 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,519 Previous Clinical Trials
4,195,877 Total Patients Enrolled
Jill M Hagey, MD, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
~1 spots leftby Jun 2025
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