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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

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

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

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 more

Other 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 • NCT05216952

67%

Fatigue

67%

Dizziness

33%

Vaginal Bleeding Requiring Hospitalization

33%

Chills

33%

Severe cramping

33%

Nausea

100%

80%

60%

40%

20%

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