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