PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Last updated: August 30, 2019
Sponsor: PregLem SA
Overall Status: Completed

Phase

3

Condition

Uterine Fibroids

Uterina Myoma

Sarcoma (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01629563
PGL11-006
  • Ages 18-50
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 ofcontraception.

Exclusion

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 ReceptorModulator (SPRM).

  • Has abnormal hepatic function at study entry.

  • Has a positive pregnancy test, is nursing or planning a pregnancy during the course ofthe 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 participatedin such a study within the last 30 days.

Study Design

Total Participants: 451
Study Start date:
June 01, 2012
Estimated Completion Date:
January 31, 2015

Study 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.

Connect with a study center

  • Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique

    Brussels, 1200
    Belgium

    Site Not Available

  • UZ Leuven Campus Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique

    Liège, 4000
    Belgium

    Site Not Available

  • CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique

    Liège, 4000
    Belgium

    Site Not Available

  • CHU Mont-Godinne

    Yvoir, 5530
    Belgium

    Site Not Available

  • Centrum ambulantni gynekologie a primarni pece

    Brno, 60200
    Czechia

    Site Not Available

  • FN Brno Gynekologicko - porodnická klinika

    Brno, 62500
    Czechia

    Site Not Available

  • Sanatorium SANUS

    Hradec Kralove, 50002
    Czechia

    Site Not Available

  • Nemocnice Jihlava Gynekologicko - porodnicke oddeleni

    Jihlava, 58633
    Czechia

    Site Not Available

  • FN Olomouc, Porodnicko-Gynekologicka klinika

    Olomouc, 77220
    Czechia

    Site Not Available

  • G-CENTRUM Olomouc s.r.o.

    Olomouc, 77200
    Czechia

    Site Not Available

  • Femina Sana, s.r.o.

    Praha 3, 13000
    Czechia

    Site Not Available

  • Hôpital Bicêtre - APHP

    Le Kremlin Bicêtre, 94275
    France

    Site Not Available

  • Hôpital Bichat, Service de Gynécologie Obstétrique

    Paris, 75018
    France

    Site Not Available

  • CHU Bretonneau Service de Gynécologie Obstétrique

    Tours, 37044
    France

    Site Not Available

  • Private practice

    Hamburg, 22159
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe

    Hannover, 30625
    Germany

    Site Not Available

  • Frauenarztpraxis

    Hessen, 60322
    Germany

    Site Not Available

  • Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung

    Magdeburg, 39112
    Germany

    Site Not Available

  • Technische Universität München

    München, 81675
    Germany

    Site Not Available

  • Rethy Pal Korhaz és Rendelointezet Szuleszeti es Nogyogyaszati Osztaly

    Bekescsaba, 5600
    Hungary

    Site Not Available

  • Institution Robert Karoly Maganklinika

    Budapest, 1135
    Hungary

    Site Not Available

  • Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo

    Debrecen, 4024
    Hungary

    Site Not Available

  • Josa Andras Oktatokorhaz

    Nyiregyhaza, 4400
    Hungary

    Site Not Available

  • Fejer Megyei Szent Gyorgy Korhaz Szuleszeti es Nogyogyaszati Osztaly

    Szekesfehervar, 8000
    Hungary

    Site Not Available

  • Szuleszeti es Nogyogyaszati Osztaly

    Szentes, 6600
    Hungary

    Site Not Available

  • Sandor Dent Bt.

    Szolnok, 5000
    Hungary

    Site Not Available

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

    Catanzaro, 88100
    Italy

    Site Not Available

  • Policlinico Universitario "Agostino Gemelli"

    Roma, 00168
    Italy

    Site Not Available

  • Latvian Medical Marine Center

    Riga, LV-1005
    Latvia

    Site Not Available

  • Medical Company "ARS"

    Riga, LV-1010
    Latvia

    Site Not Available

  • Riga 1. hospital

    Riga, 1001
    Latvia

    Site Not Available

  • Saules Family Medicine Center

    Kaunas, 49449
    Lithuania

    Site Not Available

  • Family Medicine Centre"Seimos Gydytojas"

    Vilnius, 01118
    Lithuania

    Site Not Available

  • Private Clinic "Kardiolita"

    Vilnius, 05263
    Lithuania

    Site Not Available

  • Private Clinic "Maxmeda"

    Vilnius, 03225
    Lithuania

    Site Not Available

  • Centrul Medical EUROMED SRL, Departamentul de Obtetrica/Ginecologie

    Bucuresti, 020762
    Romania

    Site Not Available

  • Centrul Medical SANA SRL

    Bucuresti, 011025
    Romania

    Site Not Available

  • Fortis Medical Center SRL Obstetrica Ginecologie

    Bucuresti, 012064
    Romania

    Site Not Available

  • Quantum Medical Center SRL Obstetrica-Ginecologie

    Bucuresti, 011426
    Romania

    Site Not Available

  • Spitalul Clinic Dr. I.Cantacuzino sectia Obstetrica-Ginecologie

    Bucuresti, 020475
    Romania

    Site Not Available

  • Spitalul Clinic de Obstetrica

    Iasi, 700398
    Romania

    Site Not Available

  • Kharkiv City Perinatal Center Gynaecological Department #1

    Kharkiv, 61176
    Ukraine

    Site Not Available

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

    Odessa, 65039
    Ukraine

    Site Not Available

  • Maternity Hospital#4 Department of Gynaecology

    Zaporizhzhya, 69065
    Ukraine

    Site Not Available

  • MRC Centre for Reproductive Health University of Edinburgh

    Edinburgh, EH16 4TJ
    United Kingdom

    Site Not Available

  • North Middlesex University Hospital NHS Trust

    London, N18 1QX
    United Kingdom

    Site Not Available

  • Women's Health, Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Norfolk & Norwich University Hospital

    Norwich, NR47UY
    United Kingdom

    Site Not Available

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