PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Phase 3

Completed

• Conditions: Uterine Fibroids
• Interventions: Drug: Ulipristal Acetate - open label

• Registration Number: NCT01642472
• Lead Sponsor: PregLem SA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-17
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Status Verified: 2015-12
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ulipristal Acetate (PGL4001) 10mg	Ulipristal Acetate - open label	Ulipristal Acetate (PGL4001)10mg daily administration

Primary Outcome Measures

Name	Time	Method
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire	18 months	Average score of the first 3 questions.

Trial Locations

Locations (16)

Medical University Vienna; 🇦🇹 Vienna, Austria

Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,; 🇧🇪 Brussels, Belgium

CHR de la Citadelle; 🇧🇪 Liège, Belgium

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa; 🇵🇱 Wroclaw, Poland

Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej; 🇵🇱 Warszawa, Poland

Cliniques Universitaires UCL de Mont-Godinne; 🇧🇪 Yvoir, Belgium

INVICTA Sp. Z o.o.; 🇵🇱 Gdańsk, Poland

Prywatna Klinika Polozniczo-Ginekologiczna; 🇵🇱 Bialystok, Poland

Private practice; 🇵🇱 Katowice, Poland

Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia; 🇵🇱 Lodz, Poland

Specjalistyczny Gabinet Ginekologiczno-Polozniczy; 🇵🇱 Lublin, Poland

Gabinet Lekarski Specjalistyczny "Sonus"; 🇵🇱 Warszawa, Poland

Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal; 🇪🇸 Barcelona, Spain

Clinica Ginecologica CEOGA; 🇪🇸 Lugo, Spain

Private Practice; 🇪🇸 Madrid, Spain

HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre; 🇪🇸 Madrid, Spain