PGL4001 Versus Placebo in Uterine Myomas - Full Text View

Sponsored by:	PregLem SA
Information provided by:	PregLem SA
ClinicalTrials.gov Identifier:	NCT00755755

Purpose

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.

Condition	Intervention	Phase
Uterine Myomas	Drug: PGL4001 (ulipristal) and iron Drug: PGL4001 matching placebo and iron	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by PregLem SA:

Primary Outcome Measures:

Primary efficacy objective of this study is to demonstrate superior efficacy of PGL4001 versus placebo to reduce excessive uterine bleeding and to reduce total myoma volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary efficacy objectives are to demonstrate superior efficacy of PGL4001 versus placebo in myoma-related symptoms such as anaemia or pain and to assess PGL4001 capacity to decrease uterine and myoma volume. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	October 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+	Drug: PGL4001 (ulipristal) and iron tablets
B: Experimental PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+	Drug: PGL4001 (ulipristal) and iron tablets
C: Placebo Comparator PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+	Drug: PGL4001 matching placebo and iron tablets

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755755

Contacts

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

Locations

Czech Republic
Gynekologicko-porodnicka klinika 1.LF UK a VFN	Recruiting
Praha, Czech Republic, 128 08
Gynekologicko-porodnicka klinika FN a MOU Brno	Recruiting
Brno, Czech Republic, 625 00
Gynekologicko-porodnicka klinika UK 2.LF a FN Motol	Recruiting
Praha, Czech Republic, 150 06
Mediva	Recruiting
Praha, Czech Republic, 110 00
Hungary
Saint George Hospital of Fejer County	Recruiting
Szekesfehervar, Hungary, 8000
Saint Borbala Hospital of Komarom-Esztergom County	Recruiting
Tatabanya, Hungary, 2800
Saint Stephen Hospital of Budapest	Recruiting
Budapest, Hungary, 1096
Rethy-Pal Hospital-Clinic Bekescsaba	Recruiting
Bekescsaba, Hungary, 5600
Dr. Bugyi Istvan Hospital	Recruiting
Szentes, Hungary, 6600
Fovarosi Bajcsy-Zsilinszky Hospital	Recruiting
Budapest, Hungary
Romania
Sectia Obstretica-Ginecologie Spitalul Clinic Dr. Ioan Cantacuzino	Recruiting
Bucharest, Romania, 70266
Central Medical Sanador	Recruiting
Bucharest, Romania, 011026
Departamentul de Obstretica Ginecologie si Nou Nascuti	Recruiting
Bucharest, Romania, 020395
Russian Federation
Russian Scientific Research Center of Radiology and Surgical Technologies	Recruiting
St.Petersburg, Russian Federation, 197758
Military Medical Academy n.a.S.M Kirov	Recruiting
St.Petersburg, Russian Federation, 194044
Northern State Medical University	Recruiting
Arkhangelsk, Russian Federation, 163001
Kursk State Medical University	Recruiting
Kursk, Russian Federation, 305035
Scientific Research Institute of Obstetrics and Gynecology n.a. D.O.Ott RAMS	Recruiting
St.Petersburg, Russian Federation, 199034
Saint-Petersburg City Alexandrovsky Hospital	Recruiting
St.Petersburg, Russian Federation, 193312
Medical Research Institute (MRI)	Recruiting
St.Petersburg, Russian Federation, 196084
OAO "Medical company IDK"	Recruiting
Samara, Russian Federation, 443067
American Medical Clinic, 39-41, Sadovaya str.,	Recruiting
St. Petersburg, Russian Federation, 190031
Ukraine
Lviv National Medical University named after Danylo Halytskyy	Recruiting
Lviv, Ukraine
City Clinical Hospital N9	Recruiting
Kiev, Ukraine

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:	PGL07-021
Study First Received:	September 18, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00755755
Health Authority:	Hungary: National Institute of Pharmacy; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: State Pharmacological Center - Ministry of Health; Czech Republic: State Institute for Drug Control; Romania: National Medicines Agency

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Myofibroma
Connective Tissue Diseases

Iron
Myoma
Leiomyoma

Additional relevant MeSH terms:

Neoplasms, Muscle Tissue
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 13, 2009