PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

NCT ID: NCT01156857

Last Updated: 2016-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-02-29

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.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

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

Group Type: EXPERIMENTAL

PGL4001, placebo

Intervention Type: DRUG

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

B

Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets).

Group Type: EXPERIMENTAL

PGL4001, progestin

Intervention Type: DRUG

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).

Interventions

PGL4001, placebo

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

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Ulipristal acetate; Ulipristal acetate

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

PregLem SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University Graz, department of obstetrics and gynecology

Graz, , Austria

Medical University Vienna, department of obstetrics and gynecology

Vienna, , Austria

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

CHR de la citadelle

Liège, , Belgium

Cliniques Universitaires UCL de Mont-Godinne

Yvoir, , Belgium

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

Private Practice

Warsaw, , Poland

Private Practice

Warsaw, , Poland

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

Warsaw, , Poland

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

Wroclaw, , Poland

Institut Universitari Dexeus Departamento de Ginecología

Barcelona, , Spain

Hospital Universitario Hebron, gynecology department

Barcelona, , Spain

Hospital Clinic i provincial de Barcelona, gynecology department

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

Private pratice

Madrid, , Spain

Hospital universitario 12 de Octubre, departamento de ginecologia

Madrid, , Spain

CHIP

Málaga, , Spain

Countries

Austria; Belgium; Poland; Spain

References

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.

Reference Type: DERIVED

PMID: 24630081 (View on PubMed)

Other Identifiers

PGL09-026

Identifier Type: -

Identifier Source: org_study_id