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

NCT04004884 | Terminated

• 1 other identifier: IIBSP-ULI-2019-05
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ulipristal Acetate; Selective Progesterone Receptor Modulators; Leiomyoma; Liver injury

Outcome Measures

Primary Outcomes (1)

• Transaminase levels

  Variations on AST or ALT blood levels during UPA treatment course.

  12 weeks

Secondary Outcomes (3)

• Gamma Glutamyl Transferase (GGT) levels

  12 weeks

• Bilirubin levels

  12 weeks

• Alkaline phosphatase (AF) levels

  12 weeks

Study Arms (1)

UPA Treatment

Women who had completed a full 12-week treatment course of Ulipristal Acetate for symptomatic uterine fibroids since September 2018

Drug: Ulipristal Acetate

Interventions

Ulipristal Acetate DRUG

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

Also known as: Esmya

UPA Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All women who had completed a full 12-week treatment course of UPA for symptomatic uterine fibroids since September 2018.

You may qualify if:

• Age 18-55 years
• Symptomatic uterine fibroids
• Being prescribed UPA as a treatment for symptomatic uterine fibroids according to regular practice.

You may not qualify if:

• Pregnancy
• Breastfeeding
• Previous or active hepatic disease
• Transaminase (AST,ALT) blood levels higher than 3 times the upper normal limit.
• Bilirubin blood levels higher than 3 times the upper normal limit.

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08027, Spain

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Josep Estadella

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: May 23, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 20, 2024

Record last verified: 2019-07

Locations

ES (1)