PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

PHASE3CompletedINTERVENTIONAL
Enrollment

209

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

November 30, 2011

Study Completion Date

February 29, 2012

Conditions
Uterine Fibroids
Interventions
DRUG

PGL4001, placebo

PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).

DRUG

PGL4001, progestin

PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets).

Trial Locations (23)

1090

Medical University Vienna, department of obstetrics and gynecology, Vienna

1200

Cliniques Universitaires Saint-Luc, Brussels

4000

CHR de la citadelle, Liège

5530

Cliniques Universitaires UCL de Mont-Godinne, Yvoir

8047

Medical University Graz, department of obstetrics and gynecology, Graz

13005

Hospital General de Ciudad Real Gynecology, Ciudad Real

19002

Hospital Universitario de Guadalajara Consultas de Ginecología (Planta 0), Guadalajara

27002

Clinica Ginecologica CEOGA, departamento de Ginecologia, Lugo

28009

Private pratice, Madrid

28041

Hospital universitario 12 de Octubre, departamento de ginecologia, Madrid

29010

CHIP, Málaga

15-224

Prywatna Klinika Polozniczo-Ginekologiczna, Bialystok

80-895

INVICTA Sp. Z o.o., Gdansk

40-724

Private Practice, Katowice

90-602

Private Practice, Lodz

20-081

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii, Lublin

00-815

Private Practice, Warsaw

02-066

Private Practice, Warsaw

02-507

Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej, Warsaw

50-369

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

08028

Institut Universitari Dexeus Departamento de Ginecología, Barcelona

08035

Hospital Universitario Hebron, gynecology department, Barcelona

08036

Hospital Clinic i provincial de Barcelona, gynecology department, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PregLem SA

INDUSTRY