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PGL4001 Versus Placebo in Uterine Myomas

Information source: PregLem SA
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Uterine Myomas

Intervention: PGL4001 (ulipristal) and iron (Drug); PGL4001 matching placebo and iron (Drug); PGL4001 (ulipristal) and iron (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: PregLem SA

Official(s) and/or principal investigator(s):
Dr Elke Bestel, Study Director, Affiliation: PregLem SA

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.

Clinical Details

Official title: A Phase III, Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of PGL4001 (Ulipristal) Versus Placebo for Pre-Operative Treatment of Symptomatic Uterine Myomas

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)

Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

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 of

contraception.

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

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

Receptor Modulator (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

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.

Locations and Contacts

Gynekologicko-porodnicka klinika FN Brno, Brno 625 00, Czech Republic

Gynekologicko-porodnicka klinika 1.LF UK a VFN, Praha 128 00, Czech Republic

Gynekologicko-porodnicka klinika UK 2.LF a FN, Praha 150 06, Czech Republic

Mediva, Praha 110 00, Czech Republic

Rethy-Pal Hospital-Clinic Bekescsaba, Department of Obstetrics and Gynecology, Bekescsaba 5600, Hungary

Fovarosi Bajcsy-Zsilinszky Hospital, Department of Obstetrics and Gynecology, Budapest 1106, Hungary

Saint Stephen Hospital of Budapest,Department of Obstetrics, Gynecology and Gynecological Oncology, Budapest 1096, Hungary

Saint George Hospital of Fejer County, Department of Obstetrics and Gynecology, Szekesfehervar 8000, Hungary

Dr. Bugyi Istvan Hospital, Department of Obstetrics and Gynecology, Szentes 6600, Hungary

Saint Borbala Hospital of Komarom-Esztergom County, Department of Obstetrics and Gynecology, Tatabanya 2800, Hungary

Dr. Jilla Hospital, Aurangabad 431001, India

Divakars Speciality Hospital, Bangalore 560078, India

M. S. Ramaiah Medical College and Memorial Hospital, Bangalore 560054, India

Sri Ramachandra Medical College and Research Institute, Chennai 600116, India

Nagpur Test Tube Baby Centre, Nagpur 440022, India

Om Women's Hospital, Nagpur 440010, India

Central Medical Sanador, Bucharest 011026, Romania

Departamentul de Obstretica Ginecologie si Nou Nascuti, Bucharest 020395, Romania

Sectia Obstretica-Ginecologie Spitalul Clinic Dr. Ioan Cantacuzino, Bucharest 70266, Romania

Centrul Medical Euromed, departementul de Obstetrica/Ginecologie, Bucuresti 020762, Romania

Spitalul Clinic de Obstetrica Ginecologie Oradea, Oradea 410053, Romania

Spitalul Clinic Judetean de urgenta, sectia de obstetrica Ginecologie I, Targu Mures 540136, Romania

Northern State Medical University, Arkhangelsk 163001, Russian Federation

Kursk State Medical University, Kursk 305035, Russian Federation

OAO "Medical company IDK", Samara 443067, Russian Federation

American Medical Clinic, St. Petersburg 190000, Russian Federation

Medical Research Institute (MRI), St.Petersburg 196084, Russian Federation

Military Medical Academy n.a.S.M Kirov, chair of Obstetrics and Gynecology, St.Petersburg 194044, Russian Federation

Russian Scientific Research Center of Radiology and Surgical Technologies, St.Petersburg 197758, Russian Federation

Saint-Petersburg City Alexandrovsky Hospital, St.Petersburg 193312, Russian Federation

Scientific Research Institute of Obstetrics and Gynecology n.a. D.O.Ott of RAMS, St.Petersburg 199034, Russian Federation

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

City Clinical Hospital N9, Kiev 04112, Ukraine

Institute of Pediatrics, Obstetrics and Gynecology, Department of Endocrine Gynecology, Kiev, Ukraine

Kiev Maternity Hospital No.2, Kiev, Ukraine

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

Lviv National Medical University named after Danylo Halytskyy, Lviv 79032, Ukraine

Medical Sanitory Centre VAT "Motor Sich" Gynecology department, Zaporizhzhya, Ukraine

Additional Information

Starting date: October 2008
Last updated: December 11, 2012

Page last updated: August 20, 2015

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