PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

NCT01629563 | Completed Phase 3 Results DMC

• 1 other identifier: PGL11-006
• Study Type: interventional
• Target: 451
• Locations: 11 countries
• Sites: 49

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.

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses

  Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days.

  18 months study duration per subject (4 3-month intermittent treatment courses)

Secondary Outcomes (6)

• Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4

  After 18 months

• Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses

  After 18 months

• Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids

  After 18 months

• Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)

  After 18 months

• Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)

  18 months

Study Arms (2)

Ulipristal acetate (PGL4001) 5mg

EXPERIMENTAL

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.

Drug: PGL4001 5 mg

Ulipristal acetate (PGL4001) 10mg

EXPERIMENTAL

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.

Drug: PGL4001 10 mg

Interventions

PGL4001 5 mg DRUG

PGL4001 5 mg daily administration

Also known as: Ulipristal Acetate, Esmya

Ulipristal acetate (PGL4001) 5mg

PGL4001 10 mg DRUG

PGL4001 10mg daily administration

Also known as: Ulipristal Acetate

Ulipristal acetate (PGL4001) 10mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PregLem SA: lead

Study Sites (49)

Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique

Brussels, 1200, Belgium

Location

UZ Leuven Campus Gasthuisberg

Leuven, 3000, Belgium

Location

CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique

Liège, 4000, Belgium

Location

CHU Mont-Godinne

Yvoir, 5530, Belgium

Location

Centrum ambulantni gynekologie a primarni pece

Brno, 60200, Czechia

Location

FN Brno Gynekologicko - porodnická klinika

Brno, 62500, Czechia

Location

Sanatorium SANUS

Hradec Králové, 50002, Czechia

Location

Nemocnice Jihlava Gynekologicko - porodnicke oddeleni

Jihlava, 58633, Czechia

Location

G-CENTRUM Olomouc s.r.o.

Olomouc, 77200, Czechia

Location

FN Olomouc, Porodnicko-Gynekologicka klinika

Olomouc, 77220, Czechia

Location

Femina Sana, s.r.o.

Prague, 13000, Czechia

Location

Hôpital Bicêtre - APHP

Le Kremlin-Bicêtre, 94275, France

Location

Hôpital Bichat, Service de Gynécologie Obstétrique

Paris, 75018, France

Location

CHU Bretonneau Service de Gynécologie Obstétrique

Tours, 37044, France

Location

Private practice

Hamburg, 22159, Germany

Location

Private practice

Hamburg, 22359, Germany

Location

Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe

Hanover, 30625, Germany

Location

Frauenarztpraxis

Hessen, 60322, Germany

Location

Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung

Magdeburg, 39112, Germany

Location

Technische Universität München

München, 81675, Germany

Location

Rethy Pal Korhaz és Rendelointezet Szuleszeti es Nogyogyaszati Osztaly

Békéscsaba, 5600, Hungary

Location

Institution Robert Karoly Maganklinika

Budapest, 1135, Hungary

Location

Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo

Debrecen, 4024, Hungary

Location

Josa Andras Oktatokorhaz

Nyíregyháza, 4400, Hungary

Location

Szuleszeti es Nogyogyaszati Osztaly

Szentes, 6600, Hungary

Location

Fejer Megyei Szent Gyorgy Korhaz Szuleszeti es Nogyogyaszati Osztaly

Székesfehérvár, 8000, Hungary

Location

Sandor Dent Bt.

Szolnok, 5000, Hungary

Location

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

Catanzaro, 88100, Italy

Location

Policlinico Universitario "Agostino Gemelli"

Roma, 00168, Italy

Location

Riga 1. hospital

Riga, 1001, Latvia

Location

Latvian Medical Marine Center

Riga, LV-1005, Latvia

Location

Medical Company "ARS"

Riga, LV-1010, Latvia

Location

Saules Family Medicine Center

Kaunas, 49449, Lithuania

Location

Family Medicine Centre"Seimos Gydytojas"

Vilnius, 01118, Lithuania

Location

Private Clinic "Maxmeda"

Vilnius, 03225, Lithuania

Location

Private Clinic "Kardiolita"

Vilnius, 05263, Lithuania

Location

Centrul Medical SANA SRL

Bucharest, 011025, Romania

Location

Quantum Medical Center SRL Obstetrica-Ginecologie

Bucharest, 011426, Romania

Location

Fortis Medical Center SRL Obstetrica Ginecologie

Bucharest, 012064, Romania

Location

Spitalul Clinic Dr. I.Cantacuzino sectia Obstetrica-Ginecologie

Bucharest, 020475, Romania

Location

Centrul Medical EUROMED SRL, Departamentul de Obtetrica/Ginecologie

Bucharest, 020762, Romania

Location

Spitalul Clinic de Obstetrica

Iași, 700398, Romania

Location

Kharkiv City Perinatal Center Gynaecological Department #1

Kharkiv, 61176, Ukraine

Location

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

Odesa, 65039, Ukraine

Location

Maternity Hospital#4 Department of Gynaecology

Zaporizhzhya, 69065, Ukraine

Location

MRC Centre for Reproductive Health University of Edinburgh

Edinburgh, EH16 4TJ, United Kingdom

Location

North Middlesex University Hospital NHS Trust

London, N18 1QX, United Kingdom

Location

Women's Health, Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Norfolk & Norwich University Hospital

Norwich, NR47UY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 26477496 DERIVED

• 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.

  PMID: 25542821 DERIVED

MeSH Terms

Conditions

Leiomyoma

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Dr Pablo Arriagada
• Organization: PregLem

info@preglem.com

0041228840355

Study Officials

• Pablo Arrigada, MD

  PregLem SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 27, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-08

Locations

IT (2); UA (3); DE (6); FR (3); BE (4); LI (4); CZ (7); RO (6); HU (7); GB (4); LA (3)