PGL4001 Versus Placebo in Uterine Myomas

Last updated: December 11, 2012
Sponsor: PregLem SA
Overall Status: Completed

Phase

3

Condition

Uterine Fibroids

Leiomyomas

Sarcoma (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00755755
PGL07-021
  • Ages 18-50
  • Female

Study Summary

This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be a pre-menopausal woman between 18 and 50 years inclusive.

  • Have excessive uterine bleeding due to myoma.

  • Have a myoma-related anaemia.

  • Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size.

  • Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.

  • If of childbearing potential the subject must be practicing a non-hormonal method ofcontraception.

  • Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

Exclusion

Exclusion Criteria:

  • Has a history of or current uterine, cervical, ovarian or breast cancer.

  • Has a history of or current endometrium atypical hyperplasia.

  • Has a known severe coagulation disorder.

  • Has a history of or current treatment for myoma with a Selective Progesterone ReceptorModulator (SPRM) or a GnRH-agonist.

  • Has abnormal hepatic function at study entry.

  • Has a positive pregnancy test at baseline or is nursing or planning a pregnancy duringthe 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 participatedin such a study within the last 30 days.

Study Design

Total Participants: 241
Study Start date:
October 01, 2008
Estimated Completion Date:
August 31, 2010

Connect with a study center

  • Gynekologicko-porodnicka klinika FN Brno

    Brno, 625 00
    Czech Republic

    Site Not Available

  • Gynekologicko-porodnicka klinika 1.LF UK a VFN

    Praha, 128 00
    Czech Republic

    Site Not Available

  • Gynekologicko-porodnicka klinika UK 2.LF a FN

    Praha, 150 06
    Czech Republic

    Site Not Available

  • Mediva

    Praha, 110 00
    Czech Republic

    Site Not Available

  • Rethy-Pal Hospital-Clinic Bekescsaba, Department of Obstetrics and Gynecology

    Bekescsaba, 5600
    Hungary

    Site Not Available

  • Fovarosi Bajcsy-Zsilinszky Hospital, Department of Obstetrics and Gynecology

    Budapest, 1106
    Hungary

    Site Not Available

  • Saint Stephen Hospital of Budapest,Department of Obstetrics, Gynecology and Gynecological Oncology

    Budapest, 1096
    Hungary

    Site Not Available

  • Saint George Hospital of Fejer County, Department of Obstetrics and Gynecology

    Szekesfehervar, 8000
    Hungary

    Site Not Available

  • Dr. Bugyi Istvan Hospital, Department of Obstetrics and Gynecology

    Szentes, 6600
    Hungary

    Site Not Available

  • Saint Borbala Hospital of Komarom-Esztergom County, Department of Obstetrics and Gynecology

    Tatabanya, 2800
    Hungary

    Site Not Available

  • Dr. Jilla Hospital

    Aurangabad, 431001
    India

    Site Not Available

  • Divakars Speciality Hospital

    Bangalore, 560078
    India

    Site Not Available

  • M. S. Ramaiah Medical College and Memorial Hospital

    Bangalore, 560054
    India

    Site Not Available

  • Sri Ramachandra Medical College and Research Institute

    Chennai, 600116
    India

    Site Not Available

  • Nagpur Test Tube Baby Centre

    Nagpur, 440022
    India

    Site Not Available

  • Om Women's Hospital

    Nagpur, 440010
    India

    Site Not Available

  • Central Medical Sanador

    Bucharest, 011026
    Romania

    Site Not Available

  • Departamentul de Obstretica Ginecologie si Nou Nascuti

    Bucharest, 020395
    Romania

    Site Not Available

  • Sectia Obstretica-Ginecologie Spitalul Clinic Dr. Ioan Cantacuzino

    Bucharest, 70266
    Romania

    Site Not Available

  • Centrul Medical Euromed, departementul de Obstetrica/Ginecologie

    Bucuresti, 020762
    Romania

    Site Not Available

  • Spitalul Clinic de Obstetrica Ginecologie Oradea

    Oradea, 410053
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de urgenta, sectia de obstetrica Ginecologie I

    Targu Mures, 540136
    Romania

    Site Not Available

  • Northern State Medical University

    Arkhangelsk, 163001
    Russian Federation

    Site Not Available

  • Kursk State Medical University

    Kursk, 305035
    Russian Federation

    Site Not Available

  • OAO "Medical company IDK"

    Samara, 443067
    Russian Federation

    Site Not Available

  • American Medical Clinic

    St. Petersburg, 190000
    Russian Federation

    Site Not Available

  • Medical Research Institute (MRI)

    St.Petersburg, 196084
    Russian Federation

    Site Not Available

  • Military Medical Academy n.a.S.M Kirov, chair of Obstetrics and Gynecology

    St.Petersburg, 194044
    Russian Federation

    Site Not Available

  • Russian Scientific Research Center of Radiology and Surgical Technologies

    St.Petersburg, 197758
    Russian Federation

    Site Not Available

  • Saint-Petersburg City Alexandrovsky Hospital

    St.Petersburg, 193312
    Russian Federation

    Site Not Available

  • Scientific Research Institute of Obstetrics and Gynecology n.a. D.O.Ott of RAMS

    St.Petersburg, 199034
    Russian Federation

    Site Not Available

  • Donetsk National Medical University, Department of Obstetrics, Gynecology and Perinatology FPE

    Donetsk,
    Ukraine

    Site Not Available

  • City Clinical Hospital N9

    Kiev, 04112
    Ukraine

    Site Not Available

  • Institute of Pediatrics, Obstetrics and Gynecology, Department of Endocrine Gynecology

    Kiev,
    Ukraine

    Site Not Available

  • Kiev Maternity Hospital No.2

    Kiev,
    Ukraine

    Site Not Available

  • State Enterprise "Institute of Pediatrics, Obstetrics and Gynecology of AMS of Ukraine

    Kyiv,
    Ukraine

    Site Not Available

  • Lviv National Medical University named after Danylo Halytskyy

    Lviv, 79032
    Ukraine

    Site Not Available

  • Medical Sanitory Centre VAT "Motor Sich" Gynecology department

    Zaporizhzhya,
    Ukraine

    Site Not Available

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