PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Drug: Ulipristal Acetate - open label


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulipristal Acetate (PGL4001) 10mg<br>Ulipristal Acetate (PGL4001)10mg daily administration | Drug: Ulipristal Acetate - open label<br>* Ulipristal Acetate (PGL4001) tablets 10mg orally daily for 3 months (84 days) for each treatment course. There are four 3-month treatment courses in this study.<br>* Other names: PGL4001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire | Average score of the first 3 questions. | 9 months | 
| Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire | Average score of the first 3 questions. | 18 months |