Clinical trial NCT01252069: PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
Official title: A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With 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: 2010-12-02
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment.

This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.


Eligibility criteria: Inclusion Criteria:

* Subject completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.

Exclusion Criteria:

* Subject has a large uterine polyp (\> 2cm).
* Subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during PGL09-026 study.
* Subject has abnormal hepatic function at re-test.
* Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or interfere with study evaluations.
* Subject has a positive pregnancy test or is planning a pregnancy during the course of the study.

Primary outcomes:
measure: percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received
timeFrame: From baseline to end of each PGL4001 treatment (3months treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, department of obstetrics and gynecology
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique
city: Liège
country: Belgium
facility: CHR de la Citadelle Gynécologie-Obstétrique
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique
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: Private practice
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii
city: Warszawa
country: Poland
facility: Private Practice
city: Warszawa
country: Poland
facility: Private practice
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 Hebron, gynecology department
city: Lugo
country: Spain
facility: Clinica Ginecologica CEOGA, departamento de Ginecologia
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 Departamento de Ginecología
city: Malaga
country: Spain
facility: CHIP (Complejo Hospitalario Integral Privado)
Study officials:
References:
citation: Donnez J, Vazquez F, Tomaszewski J, Nouri K, Bouchard P, Fauser BC, Barlow DH, Palacios S, Donnez O, Bestel E, Osterloh I, Loumaye E; PEARL III and PEARL III Extension Study Group. Long-term treatment of uterine fibroids with ulipristal acetate ☆. Fertil Steril. 2014 Jun;101(6):1565-73.e1-18. doi: 10.1016/j.fertnstert.2014.02.008. Epub 2014 Mar 12.