Your session is about to expire
← Back to Search
Prostaglandin E1 Analog
Ulipristal Acetate for Use in Early Pregnancy Loss
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
No Placebo-Only Group
Summary
This trial is testing a combination of two medications, ulipristal acetate and misoprostol, to help women manage early pregnancy loss without surgery. It targets women over 18 who have lost a pregnancy in the early stages. Ulipristal acetate makes the body more responsive to misoprostol, which helps clear the pregnancy tissue.
Eligible Conditions
- Miscarriage
- Blighted Ovum
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from admission until day 30 follow up, +/- 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from admission until day 30 follow up, +/- 7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Adherent to Study Protocol
Percentage of Participants Recruited to Study Protocol
Percentage of Participants Retained in Study Protocol
Secondary study objectives
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 moreOther study objectives
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 • NCT0521695267%
Fatigue
67%
Dizziness
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
59 Previous Clinical Trials
4,455 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,561 Previous Clinical Trials
4,298,738 Total Patients Enrolled
Jill M Hagey, MD, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill