Clinical trial NCT01156857: PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Official title: A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, 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: 2010-07-05
Enrollment: 209
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 a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.

Detailed description: PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.

Eligibility criteria: Inclusion Criteria:

* Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
* Subject with a Body Mass Index ≥18 and ≤40.
* Subject with myomatous uterus size \< 16 weeks.
* Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.
* Subject complained of strong uterine bleeding.
* Subject is eligible for hysterectomy or myomectomy.
* Females of childbearing potential have to practice a non-hormonal method of contraception.

Exclusion Criteria:

* Subject has a history of or current uterus, cervix, ovarian or breast cancer.
* Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.
* Subject has a known severe coagulation disorder.
* Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
* Subject has abnormal hepatic function at study entry.

Primary outcomes:
measure: Efficacy endpoints
timeFrame: From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.
measure: Number and proportion of subjects experiencing open label treatment-emergent adverse events
timeFrame: From baseline to end of PGL4001 treatment (3months treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz, department of obstetrics and gynecology
city: Vienna
country: Austria
facility: Medical University Vienna, department of obstetrics and gynecology
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
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: 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: Institut Universitari Dexeus Departamento de Ginecología
city: Barcelona
country: Spain
facility: Hospital Universitario Hebron, gynecology department
city: Barcelona
country: Spain
facility: Hospital Clinic i provincial de Barcelona, gynecology department
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real Gynecology
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara Consultas de Ginecología (Planta 0)
city: Lugo
country: Spain
facility: Clinica Ginecologica CEOGA, departamento de Ginecologia
city: Madrid
country: Spain
facility: Private pratice
city: Madrid
country: Spain
facility: Hospital universitario 12 de Octubre, departamento de ginecologia
city: Malaga
country: Spain
facility: CHIP
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.