PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Uterine Fibroids Clinical Trial

— PEARLext2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642472
• Other study ID #: PGL11-024
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2012
• Last updated: January 7, 2016
• Start date: July 2012
• Est. completion date: April 2015

Study information

• Verified date: December 2015
• Source: PregLem SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsPoland: Ministry of HealthAustria: Federal Office for Safety in Health CareSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Ulipristal 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.

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna
Belgium	Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,	Brussels
Belgium	CHR de la Citadelle	Liège
Belgium	Cliniques Universitaires UCL de Mont-Godinne	Yvoir
Poland	Prywatna Klinika Polozniczo-Ginekologiczna	Bialystok
Poland	INVICTA Sp. Z o.o.	Gdansk
Poland	Private practice	Katowice
Poland	Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia	Lodz
Poland	Specjalistyczny Gabinet Ginekologiczno-Polozniczy	Lublin
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej	Warszawa
Poland	Gabinet Lekarski Specjalistyczny "Sonus"	Warszawa
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, I Katedra i Klinika Ginekologii i Poloznictwa	Wroclaw
Spain	Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal	Barcelona
Spain	Clinica Ginecologica CEOGA	Lugo
Spain	HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre	Madrid
Spain	Private Practice	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
PregLem SA

Countries where clinical trial is conducted

Austria,  Belgium,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire	Average score of the first 3 questions.	9 months	No
Primary	Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire	Average score of the first 3 questions.	18 months	No