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Liver Safety Assessment During Ulipristal Acetate Treatment for Uterine Fibroids (LISA)

NCT04004884 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-05-20

No results posted yet for this study

Summary

Uterine fibroids are are the most common gynecological tumor. Among the pharmacological treatment options, ulipristal acetate (UPA) has proven to be effective in control of bleeding and reduction of size of fibroids.

Due to the appearance of some cases of subacute severe hepatic insufficiency in patients undergoing UPA treatment and the possible idiosyncratic effect of the drug, the European Medicine Agency (EMA) recommended performing liver function tests before, during and after each UPA treatment course as a minimization risk strategy to prevent drug induced liver injury (DILI).

The aim of the present study is to evaluate whether changes in transaminase levels or other DILI markers occur in patients receiving UPA in our center.

Conditions

  • Leiomyoma, Uterine
  • Liver Injury
  • Treatment Side Effects

Interventions

DRUG

Ulipristal Acetate

Assess the variations of liver blood test parameters during UPA treatment for symptomatic uterine fibroids

Sponsors & Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Principal Investigators

  • Josep Estadella · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-23
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Spain

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 NCT04004884 on ClinicalTrials.gov