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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01642472

Acronym

PEARLext2

Enrollment

Registered

2012-07-17

Start date

2012-07-31

Completion date

2015-04-30

Last updated

2016-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroids

Brief summary

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.

Interventions

DRUGUlipristal Acetate - open label

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Austria, Belgium, Poland, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026