Clinical trial · Observational
Liver Safety Assessment During Ulipristal Acetate Treatment for Uterine Fibroids (LISA)
Liver Safety Assessment During Ulipristal Acetate Treatment for Uterine Fibroids
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of recruitment
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma, Uterine | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Liver Injury | — | UNRESOLVED | — |
| Treatment Side Effects | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ulipristal Acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- UPA Treatment
- description
- Women who had completed a full 12-week treatment course of Ulipristal Acetate for symptomatic uterine fibroids since September 2018
- interventionNames
- Drug: Ulipristal Acetate
Primary outcomes (1)
- measure
- Transaminase levels
- timeFrame
- 12 weeks
- description
- Variations on AST or ALT blood levels during UPA treatment course.
Secondary outcomes (3)
- measure
- Gamma Glutamyl Transferase (GGT) levels
- timeFrame
- 12 weeks
- description
- Variations on GGT blood levels during UPA treatment course.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-55 years * Symptomatic uterine fibroids * Being prescribed UPA as a treatment for symptomatic uterine fibroids according to regular practice. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available