PGL4001 Versus GnRH-Agonist in Uterine Myomas - Full Text View

Sponsored by:	PregLem SA
Information provided by:	PregLem SA
ClinicalTrials.gov Identifier:	NCT00740831

Purpose

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

Condition	Intervention	Phase
Uterine Myomas	Drug: PGL4001, ulipristal Drug: leuprorelin	Phase III

Drug Information available for: Gonadorelin Gonadorelin hydrochloride LH-RH

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Randomised, Parallel Group, Double-Blind, Double-Dummy, Active Comparator-Controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001(Ulipristal)Versus GnRH-Agonist(Leuprorelin 3.75mg) for Pre-Operative Treatment of Symptomatic Uterine Myomas.

Further study details as provided by PregLem SA:

Primary Outcome Measures:

Primary efficacy objective of this study is to compare efficacy of PGL4001 versus GnRH-agonist to reduce excessive uterine bleeding. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary efficacy objectives are to demonstrate improvement over baseline in myoma-related symptoms such as impaired QoL and pain and to assess PGL4001 capacity to decrease uterine and myoma volume. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	August 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Drug: PGL4001 5mg (oral tablets) and saline intramuscular injection	Drug: PGL4001, ulipristal tablets
B: Experimental Drug: PGL4001 10 mg (oral tablets) and saline intramuscular injection	Drug: PGL4001, ulipristal tablets
C: Active Comparator PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)	Drug: leuprorelin solution for injection

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Be a pre-menopausal woman between 18 and 50 years inclusive.
Have excessive uterine bleeding due to myoma
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 or adenocarcinoma.
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 a history of or known current osteoporosis.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740831

Contacts

Contact: Dr Elke Bestel	+41228840357	medical@preglem.com
Contact: Dr Ernest Loumaye

Locations

Austria
Medical University Graz	Recruiting
Graz, Austria, 8036
Vienna University Medical School	Recruiting
Vienna, Austria, 1090
Medical University of Innsbruck	Recruiting
Innsbruck, Austria, 6020
Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology	Not yet recruiting
Neunkirchen, Austria, 2620
Belgium
Université Catholique de Louvain	Recruiting
Brussels, Belgium, 1200
Clinique Universitaire de Mont-Godinne	Recruiting
Yvoir, Belgium, 5530
CHR de la Citadelle	Recruiting
Liège, Belgium, 4000
Hopital Erasme, Department of Obstetrics and Gynecology,	Recruiting
Brussels, Belgium, 1070
Germany
Dr. med. Werner Göttker-Schnetmann Facharzt für Frauenheilkunde und Geburtshilfe	Recruiting
Frankfurt, Germany, 60322
Poliklinik fur Frauenheilkunde und Geburtshilfe	Recruiting
Münster, Germany, 48149
Medizinische Hochschule Hannover, Frauenklinik, Abt. I für Frauenheilkunde und Geburtshilfe,	Recruiting
Hannover, Germany, 30625
Israel
Rabin Medical Center, Helen Schneider Hospital for Women	Recruiting
Petach Tikva, Israel, 49100
Soroka University Medical Center, Division of Obstetrics & Gynecology	Recruiting
Be'er Sheva, Israel, 84101
Meir Medical Center	Recruiting
Kfar-Saba, Israel
Italy
Policlinico Universitario "Agostino Gemelli"	Recruiting
Roma, Italy, 00168
Clinica Ostetrica e Ginecologica - A. O. U. Policlinico Paolo Giaccone	Recruiting
Palermo, Italy, 70100
Spain
Hospital Clínic i Provincial	Not yet recruiting
Barcelona, Spain, 08036
Institut Universitari Dexeus	Not yet recruiting
Barcelona, Spain, 08028
Clínica Ginecológica CEOGA	Recruiting
Lugo, Spain, 27002
Instituto Palacios	Recruiting
Madrid, Spain, 28009
Hospital Universitario Dr. Peset	Not yet recruiting
Valencia, Spain, 46017
Hospital Universitario Vall d'Hebrón	Recruiting
Barcelona, Spain, 08035

Sponsors and Collaborators

PregLem SA

Investigators

Study Director:

Dr Elke Bestel

PregLem SA

More Information

Responsible Party:	PregLem SA ( Dr Elke Bestel )
Study ID Numbers:	PGL07-022
Study First Received:	August 22, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00740831
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; Belgium: Institutional Review Board; Austria: Agency for Health and Food Safety; Austria: Ethikkommission; Italy: Ethics Committee; Spain: Comité Ético de Investigación Clínica; Spain: Spanish Agency of Medicines; Israel: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by PregLem SA:

Uterine Myomas

Study placed in the following topic categories:

Deslorelin
Neoplasms, Connective and Soft Tissue
Myofibroma
Leuprolide

Connective Tissue Diseases
Myoma
Leiomyoma

Additional relevant MeSH terms:

Neoplasms, Muscle Tissue
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female

Therapeutic Uses
Physiological Effects of Drugs
Fertility Agents
Reproductive Control Agents
Neoplasms, Connective Tissue
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009