PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

NCT ID: NCT01629563

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 451 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-01-31

Brief Summary

Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.

Detailed Description

The target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.

Conditions

Uterine Fibroids

Study Design

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

Study Groups

Ulipristal acetate (PGL4001) 5mg

All subjects will be asked to take a 150mg size tablet (PGL4001 5mg or matching placebo: placebo 5) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 150mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.

Group Type: EXPERIMENTAL

PGL4001 5 mg

Intervention Type: DRUG

PGL4001 5 mg daily administration

Ulipristal acetate (PGL4001) 10mg

All subjects will be asked to take a 300mg size tablet (PGL4001 10mg or matching placebo: placebo 10 ) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 300mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.

Group Type: EXPERIMENTAL

PGL4001 10 mg

Intervention Type: DRUG

PGL4001 10mg daily administration

Interventions

PGL4001 5 mg

PGL4001 5 mg daily administration

Intervention Type: DRUG

PGL4001 10 mg

PGL4001 10mg daily administration

Intervention Type: DRUG

Other Intervention Names

Ulipristal Acetate, Esmya; Ulipristal Acetate

Eligibility Criteria

Inclusion Criteria

• Be a pre-menopausal woman between 18 and 50 years inclusive.
• Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
• Have FSH levels ≤ 20 mIU/mL
• Have excessive uterine bleeding due to myoma.
• Have regular menstrual cycles
• Have a myomatous uterus < 16 weeks with at least one myoma ≥ 3 cm in diameter.
• If of childbearing potential the subject must be practicing a non-hormonal method of contraception.

Exclusion Criteria

• Has a history of or current uterine, cervical, ovarian or breast cancer.
• Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
• Has a known severe coagulation disorder.
• Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM).
• Has abnormal hepatic function at study entry.
• Has a positive pregnancy test, is nursing or planning a pregnancy during the course of the study.
• Has a current (within twelve months) problem with alcohol or drug abuse.
• Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

PregLem SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pablo Arrigada, MD

Role: STUDY_DIRECTOR

PregLem SA

Locations

Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique

Brussels, , Belgium

UZ Leuven Campus Gasthuisberg

Leuven, , Belgium

CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique

Liège, , Belgium

CHU Mont-Godinne

Yvoir, , Belgium

Centrum ambulantni gynekologie a primarni pece

Brno, , Czechia

FN Brno Gynekologicko - porodnická klinika

Brno, , Czechia

Sanatorium SANUS

Hradec Králové, , Czechia

Nemocnice Jihlava Gynekologicko - porodnicke oddeleni

Jihlava, , Czechia

G-CENTRUM Olomouc s.r.o.

Olomouc, , Czechia

FN Olomouc, Porodnicko-Gynekologicka klinika

Olomouc, , Czechia

Femina Sana, s.r.o.

Prague, , Czechia

Hôpital Bicêtre - APHP

Le Kremlin-Bicêtre, , France

Hôpital Bichat, Service de Gynécologie Obstétrique

Paris, , France

CHU Bretonneau Service de Gynécologie Obstétrique

Tours, , France

Private practice

Hamburg, , Germany

Private practice

Hamburg, , Germany

Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe

Hanover, , Germany

Frauenarztpraxis

Hessen, , Germany

Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung

Magdeburg, , Germany

Technische Universität München

München, , Germany

Rethy Pal Korhaz és Rendelointezet Szuleszeti es Nogyogyaszati Osztaly

Békéscsaba, , Hungary

Institution Robert Karoly Maganklinika

Budapest, , Hungary

Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo

Debrecen, , Hungary

Josa Andras Oktatokorhaz

Nyíregyháza, , Hungary

Szuleszeti es Nogyogyaszati Osztaly

Szentes, , Hungary

Fejer Megyei Szent Gyorgy Korhaz Szuleszeti es Nogyogyaszati Osztaly

Székesfehérvár, , Hungary

Sandor Dent Bt.

Szolnok, , Hungary

Dipartimento di Ostetricia e Ginecologia, Università degli Studi di Catanzaro "Magna Graecia"

Catanzaro, , Italy

Policlinico Universitario "Agostino Gemelli"

Roma, , Italy

Riga 1. hospital

Riga, , Latvia

Latvian Medical Marine Center

Riga, , Latvia

Medical Company "ARS"

Riga, , Latvia

Saules Family Medicine Center

Kaunas, , Lithuania

Family Medicine Centre"Seimos Gydytojas"

Vilnius, , Lithuania

Private Clinic "Maxmeda"

Vilnius, , Lithuania

Private Clinic "Kardiolita"

Vilnius, , Lithuania

Centrul Medical SANA SRL

Bucharest, , Romania

Quantum Medical Center SRL Obstetrica-Ginecologie

Bucharest, , Romania

Fortis Medical Center SRL Obstetrica Ginecologie

Bucharest, , Romania

Spitalul Clinic Dr. I.Cantacuzino sectia Obstetrica-Ginecologie

Bucharest, , Romania

Centrul Medical EUROMED SRL, Departamentul de Obtetrica/Ginecologie

Bucharest, , Romania

Spitalul Clinic de Obstetrica

Iași, , Romania

Kharkiv City Perinatal Center Gynaecological Department #1

Kharkiv, , Ukraine

Municipal Institution "Maternity Hospital #1" City Center of family planning

Odesa, , Ukraine

Maternity Hospital#4 Department of Gynaecology

Zaporizhzhya, , Ukraine

MRC Centre for Reproductive Health University of Edinburgh

Edinburgh, , United Kingdom

North Middlesex University Hospital NHS Trust

London, , United Kingdom

Women's Health, Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Norfolk & Norwich University Hospital

Norwich, , United Kingdom

Countries

Belgium; Czechia; France; Germany; Hungary; Italy; Latvia; Lithuania; Romania; Ukraine; United Kingdom

References

Donnez J, Donnez O, Matule D, Ahrendt HJ, Hudecek R, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Loumaye E. Long-term medical management of uterine fibroids with ulipristal acetate. Fertil Steril. 2016 Jan;105(1):165-173.e4. doi: 10.1016/j.fertnstert.2015.09.032. Epub 2015 Oct 23.

Reference Type: DERIVED

PMID: 26477496 (View on PubMed)

Donnez J, Hudecek R, Donnez O, Matule D, Arhendt HJ, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Terrill P, Osterloh I, Loumaye E. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015 Feb;103(2):519-27.e3. doi: 10.1016/j.fertnstert.2014.10.038. Epub 2014 Dec 24.

Reference Type: DERIVED

PMID: 25542821 (View on PubMed)

Other Identifiers

PGL11-006

Identifier Type: -

Identifier Source: org_study_id