Clinical trial · Interventional
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
A Phase III, Multicentre, Extension Study Investigating the Efficacy and Safety of Repeated Intermittent 3-month Courses of Open-label Administration of Ulipristal Acetate, in Subjects With Symptomatic Uterine Myomas and Heavy Uterine Bleeding
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl extension 2 (PGL11-024). This proposed study consists of 4 further consecutive courses of 3 months (84 days) open label ulipristal acetate 10mg once daily treatment each separated by a drug free period.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ulipristal Acetate - open label | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ulipristal Acetate (PGL4001) 10mg
- description
- Ulipristal Acetate (PGL4001)10mg daily administration
- interventionNames
- Drug: Ulipristal Acetate - open label
Primary outcomes (2)
- measure
- Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
- timeFrame
- 9 months
- description
- Average score of the first 3 questions.
- measure
- Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
- timeFrame
- 18 months
- description
- Average score of the first 3 questions.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject completed visit F - Follow-up of Pearl III extension study (PGL09-027) - without significant deviations. * Females of childbearing potential are advised to practice a non-hormonal method of contraception. Exclusion Criteria: * Subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in Pearl III extension (PGL09-027) or afterwards that would interfere with the study assessments. * Subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol. * Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study. * Subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject's safety or interfere with study evaluations.
References
Publications (0)
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