Clinical trial NCT01642472: PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Fibroids
Lead sponsor: PregLem SA
Sponsor class: INDUSTRY
First posted: 2012-07-17
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
timeFrame: 9 months
measure: Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,
city: Liège
country: Belgium
facility: CHR de la Citadelle
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Godinne
city: Bialystok
country: Poland
facility: Prywatna Klinika Polozniczo-Ginekologiczna
city: Gdańsk
country: Poland
facility: INVICTA Sp. Z o.o.
city: Katowice
country: Poland
facility: Private practice
city: Lodz
country: Poland
facility: Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia
city: Lublin
country: Poland
facility: Specjalistyczny Gabinet Ginekologiczno-Polozniczy
city: Warszawa
country: Poland
facility: Gabinet Lekarski Specjalistyczny "Sonus"
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa
city: Barcelona
country: Spain
facility: Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal
city: Lugo
country: Spain
facility: Clinica Ginecologica CEOGA
city: Madrid
country: Spain
facility: Private Practice
city: Madrid
country: Spain
facility: HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre
Study officials:
affiliation: PregLem SA
name: Elke Bestel, Dr
role: STUDY_DIRECTOR
References: