Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
241 participants
INTERVENTIONAL
2008-10-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A (PGL4001 5mg)
PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
PGL4001 (ulipristal) and iron
tablets
B (PGL4001 10mg)
PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
PGL4001 (ulipristal) and iron
Tablets
C (placebo)
PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
PGL4001 matching placebo and iron
tablets
Interventions
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PGL4001 (ulipristal) and iron
tablets
PGL4001 matching placebo and iron
tablets
PGL4001 (ulipristal) and iron
Tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
50 Years
FEMALE
No
Sponsors
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PregLem SA
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Elke Bestel
Role: STUDY_DIRECTOR
PregLem SA
Locations
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Gynekologicko-porodnicka klinika FN Brno
Brno, , Czechia
Mediva
Prague, , Czechia
Gynekologicko-porodnicka klinika 1.LF UK a VFN
Prague, , Czechia
Gynekologicko-porodnicka klinika UK 2.LF a FN
Prague, , Czechia
Rethy-Pal Hospital-Clinic Bekescsaba, Department of Obstetrics and Gynecology
Békéscsaba, , Hungary
Saint Stephen Hospital of Budapest,Department of Obstetrics, Gynecology and Gynecological Oncology
Budapest, , Hungary
Fovarosi Bajcsy-Zsilinszky Hospital, Department of Obstetrics and Gynecology
Budapest, , Hungary
Dr. Bugyi Istvan Hospital, Department of Obstetrics and Gynecology
Szentes, , Hungary
Saint George Hospital of Fejer County, Department of Obstetrics and Gynecology
Székesfehérvár, , Hungary
Saint Borbala Hospital of Komarom-Esztergom County, Department of Obstetrics and Gynecology
Tatabánya, , Hungary
Dr. Jilla Hospital
Aurangabad, , India
M. S. Ramaiah Medical College and Memorial Hospital
Bangalore, , India
Divakars Speciality Hospital
Bangalore, , India
Sri Ramachandra Medical College and Research Institute
Chennai, , India
Om Women's Hospital
Nagpur, , India
Nagpur Test Tube Baby Centre
Nagpur, , India
Central Medical Sanador
Bucharest, , Romania
Departamentul de Obstretica Ginecologie si Nou Nascuti
Bucharest, , Romania
Centrul Medical Euromed, departementul de Obstetrica/Ginecologie
Bucharest, , Romania
Sectia Obstretica-Ginecologie Spitalul Clinic Dr. Ioan Cantacuzino
Bucharest, , Romania
Spitalul Clinic de Obstetrica Ginecologie Oradea
Oradea, , Romania
Spitalul Clinic Judetean de urgenta, sectia de obstetrica Ginecologie I
Târgu Mureş, , Romania
Northern State Medical University
Arkhangelsk, , Russia
Kursk State Medical University
Kursk, , Russia
American Medical Clinic
Saint Petersburg, , Russia
Saint-Petersburg City Alexandrovsky Hospital
Saint Petersburg, , Russia
Military Medical Academy n.a.S.M Kirov, chair of Obstetrics and Gynecology
Saint Petersburg, , Russia
Medical Research Institute (MRI)
Saint Petersburg, , Russia
Russian Scientific Research Center of Radiology and Surgical Technologies
Saint Petersburg, , Russia
Scientific Research Institute of Obstetrics and Gynecology n.a. D.O.Ott of RAMS
Saint Petersburg, , Russia
OAO "Medical company IDK"
Samara, , Russia
Donetsk National Medical University, Department of Obstetrics, Gynecology and Perinatology FPE
Donetsk, , Ukraine
City Clinical Hospital N9
Kiev, , 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, , Ukraine
Medical Sanitory Centre VAT "Motor Sich" Gynecology department
Zaporizhzhya, , Ukraine
Countries
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References
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Donnez J, Tatarchuk TF, Bouchard P, Puscasiu L, Zakharenko NF, Ivanova T, Ugocsai G, Mara M, Jilla MP, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL I Study Group. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012 Feb 2;366(5):409-20. doi: 10.1056/NEJMoa1103182.
Barlow DH, Lumsden MA, Fauser BC, Terrill P, Bestel E. Individualized vaginal bleeding experience of women with uterine fibroids in the PEARL I randomized controlled trial comparing the effects of ulipristal acetate or placebo. Hum Reprod. 2014 Mar;29(3):480-9. doi: 10.1093/humrep/det467. Epub 2014 Jan 23.
Other Identifiers
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PGL07-021
Identifier Type: -
Identifier Source: org_study_id