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Ulipristal Acetate for Use in Early Pregnancy Loss

NCT05216952 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-06-28

Study results available
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Summary

The investigators will study the feasibility of using 90mg ulipristal acetate, a selective progesterone receptor agonist, as an adjunct to 800mcg vaginal misoprostol for the medical management of early pregnancy loss. Patients will be followed to assess effective treatment of early pregnancy loss, additional interventions needed, side effects, adverse events and patient acceptability.

Conditions

  • Missed Abortion
  • Anembryonic Pregnancy
  • Non-Viable Pregnancy

Interventions

DRUG

Ulipristal Acetate Tablets

90mg (three 30mg tablets) administered orally once

DRUG

Misoprostol Pill

800mcg (four 200mcg pills) administered vaginally once 6-18 hours following ulipristal acetate

Sponsors & Collaborators

  • North Carolina Translational and Clinical Sciences Institute

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Jill M Hagey, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-11
Primary Completion
2023-01-03
Completion
2023-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05216952 on ClinicalTrials.gov