Clinical trial NCT00755755: PGL4001 Versus Placebo in Uterine Myomas
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Myomas
Lead sponsor: PregLem SA
Sponsor class: INDUSTRY
First posted: 2008-09-19
Enrollment: 241
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: Week 13 visit
measure: 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)
timeFrame: Week 13
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Gynekologicko-porodnicka klinika FN Brno
city: Praha
country: Czech Republic
facility: Mediva
city: Praha
country: Czech Republic
facility: Gynekologicko-porodnicka klinika 1.LF UK a VFN
city: Praha
country: Czech Republic
facility: Gynekologicko-porodnicka klinika UK 2.LF a FN
city: Bekescsaba
country: Hungary
facility: Rethy-Pal Hospital-Clinic Bekescsaba, Department of Obstetrics and Gynecology
city: Budapest
country: Hungary
facility: Saint Stephen Hospital of Budapest,Department of Obstetrics, Gynecology and Gynecological Oncology
city: Budapest
country: Hungary
facility: Fovarosi Bajcsy-Zsilinszky Hospital, Department of Obstetrics and Gynecology
city: Szekesfehervar
country: Hungary
facility: Saint George Hospital of Fejer County, Department of Obstetrics and Gynecology
city: Szentes
country: Hungary
facility: Dr. Bugyi Istvan Hospital, Department of Obstetrics and Gynecology
city: Tatabanya
country: Hungary
facility: Saint Borbala Hospital of Komarom-Esztergom County, Department of Obstetrics and Gynecology
city: Aurangabad
country: India
facility: Dr. Jilla Hospital
city: Bangalore
country: India
facility: M. S. Ramaiah Medical College and Memorial Hospital
city: Bangalore
country: India
facility: Divakars Speciality Hospital
city: Chennai
country: India
facility: Sri Ramachandra Medical College and Research Institute
city: Nagpur
country: India
facility: Om Women's Hospital
city: Nagpur
country: India
facility: Nagpur Test Tube Baby Centre
city: Bucharest
country: Romania
facility: Central Medical Sanador
city: Bucharest
country: Romania
facility: Departamentul de Obstretica Ginecologie si Nou Nascuti
city: Bucharest
country: Romania
facility: Sectia Obstretica-Ginecologie Spitalul Clinic Dr. Ioan Cantacuzino
city: Bucuresti
country: Romania
facility: Centrul Medical Euromed, departementul de Obstetrica/Ginecologie
city: Oradea
country: Romania
facility: Spitalul Clinic de Obstetrica Ginecologie Oradea
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de urgenta, sectia de obstetrica Ginecologie I
city: Arkhangelsk
country: Russian Federation
facility: Northern State Medical University
city: Kursk
country: Russian Federation
facility: Kursk State Medical University
city: Samara
country: Russian Federation
facility: OAO "Medical company IDK"
city: St. Petersburg
country: Russian Federation
facility: American Medical Clinic
city: St.Petersburg
country: Russian Federation
facility: Saint-Petersburg City Alexandrovsky Hospital
city: St.Petersburg
country: Russian Federation
facility: Military Medical Academy n.a.S.M Kirov, chair of Obstetrics and Gynecology
city: St.Petersburg
country: Russian Federation
facility: Medical Research Institute (MRI)
city: St.Petersburg
country: Russian Federation
facility: Russian Scientific Research Center of Radiology and Surgical Technologies
city: St.Petersburg
country: Russian Federation
facility: Scientific Research Institute of Obstetrics and Gynecology n.a. D.O.Ott of RAMS
city: Donetsk
country: Ukraine
facility: Donetsk National Medical University, Department of Obstetrics, Gynecology and Perinatology FPE
city: Kiev
country: Ukraine
facility: City Clinical Hospital N9
city: Kiev
country: Ukraine
facility: Institute of Pediatrics, Obstetrics and Gynecology, Department of Endocrine Gynecology
city: Kiev
country: Ukraine
facility: Kiev Maternity Hospital No.2
city: Kyiv
country: Ukraine
facility: State Enterprise "Institute of Pediatrics, Obstetrics and Gynecology of AMS of Ukraine
city: Lviv
country: Ukraine
facility: Lviv National Medical University named after Danylo Halytskyy
city: Zaporizhzhya
country: Ukraine
facility: Medical Sanitory Centre VAT "Motor Sich" Gynecology department
Study officials:
affiliation: PregLem SA
name: Dr Elke Bestel
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.