PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Uterine Fibroids Clinical Trial

— PEARLIII  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156857
• Other study ID #: PGL09-026
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2010
• Last updated: January 14, 2016
• Start date: July 2010
• Est. completion date: February 2012

Study information

• Verified date: June 2013
• Source: PregLem SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsPoland: Ministry of HealthSpain: Spanish Agency of MedicinesAustria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Graz, department of obstetrics and gynecology	Graz
Austria	Medical University Vienna, department of obstetrics and gynecology	Vienna
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
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	Private Practice	Lodz
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii	Lublin
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej	Warszawa
Poland	Private Practice	Warszawa
Poland	Private Practice	Warszawa
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, I Katedra i Klinika Ginekologii i Poloznictwa	Wroclaw
Spain	Hospital Clinic i provincial de Barcelona, gynecology department	Barcelona
Spain	Hospital Universitario Hebron, gynecology department	Barcelona
Spain	Institut Universitari Dexeus Departamento de Ginecología	Barcelona
Spain	Hospital General de Ciudad Real Gynecology	Ciudad Real
Spain	Hospital Universitario de Guadalajara Consultas de Ginecología (Planta 0)	Guadalajara
Spain	Clinica Ginecologica CEOGA, departamento de Ginecologia	Lugo
Spain	Hospital universitario 12 de Octubre, departamento de ginecologia	Madrid
Spain	Private pratice	Madrid
Spain	CHIP	Malaga

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	Efficacy endpoints	Investigate efficacy of PGL4001 on uterine bleeding (% of subjects in amenorrhea at end of PGL4001 treatment), myoma size (transvaginal ultrasound), pain (short Mc Gill questionnaire) and quality of life (specific UFS-QoL questionnaire and general EQ-5D questionnaire).	From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.	No
Primary	Number and proportion of subjects experiencing open label treatment-emergent adverse events		From baseline to end of PGL4001 treatment (3months treatment)	Yes