PGL4001 Versus Placebo in Uterine Myomas

Uterine Myomas Clinical Trial

— PEARLI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755755
• Other study ID #: PGL07-021
• Status: Completed
• Phase: Phase 3
• First received: September 18, 2008
• Last updated: December 11, 2012
• Start date: October 2008
• Est. completion date: August 2010

Study information

• Verified date: December 2012
• Source: PregLem SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of PharmacyRussia: Ministry of Health of the Russian FederationUkraine: State Pharmacological Center - Ministry of HealthCzech Republic: State Institute for Drug ControlRomania: National Medicines AgencyIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: August 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Myoma
• Uterine Myomas

Intervention

Drug:
• PGL4001 (ulipristal) and iron
tablets
• PGL4001 matching placebo and iron
tablets
• PGL4001 (ulipristal) and iron
Tablets

Locations

Country	Name	City	State
Czech Republic	Gynekologicko-porodnicka klinika FN Brno	Brno
Czech Republic	Gynekologicko-porodnicka klinika 1.LF UK a VFN	Praha
Czech Republic	Gynekologicko-porodnicka klinika UK 2.LF a FN	Praha
Czech Republic	Mediva	Praha
Hungary	Rethy-Pal Hospital-Clinic Bekescsaba, Department of Obstetrics and Gynecology	Bekescsaba
Hungary	Fovarosi Bajcsy-Zsilinszky Hospital, Department of Obstetrics and Gynecology	Budapest
Hungary	Saint Stephen Hospital of Budapest,Department of Obstetrics, Gynecology and Gynecological Oncology	Budapest
Hungary	Saint George Hospital of Fejer County, Department of Obstetrics and Gynecology	Szekesfehervar
Hungary	Dr. Bugyi Istvan Hospital, Department of Obstetrics and Gynecology	Szentes
Hungary	Saint Borbala Hospital of Komarom-Esztergom County, Department of Obstetrics and Gynecology	Tatabanya
India	Dr. Jilla Hospital	Aurangabad
India	Divakars Speciality Hospital	Bangalore
India	M. S. Ramaiah Medical College and Memorial Hospital	Bangalore
India	Sri Ramachandra Medical College and Research Institute	Chennai
India	Nagpur Test Tube Baby Centre	Nagpur
India	Om Women's Hospital	Nagpur
Romania	Central Medical Sanador	Bucharest
Romania	Departamentul de Obstretica Ginecologie si Nou Nascuti	Bucharest
Romania	Sectia Obstretica-Ginecologie Spitalul Clinic Dr. Ioan Cantacuzino	Bucharest
Romania	Centrul Medical Euromed, departementul de Obstetrica/Ginecologie	Bucuresti
Romania	Spitalul Clinic de Obstetrica Ginecologie Oradea	Oradea
Romania	Spitalul Clinic Judetean de urgenta, sectia de obstetrica Ginecologie I	Targu Mures
Russian Federation	Northern State Medical University	Arkhangelsk
Russian Federation	Kursk State Medical University	Kursk
Russian Federation	OAO "Medical company IDK"	Samara
Russian Federation	American Medical Clinic	St. Petersburg
Russian Federation	Medical Research Institute (MRI)	St.Petersburg
Russian Federation	Military Medical Academy n.a.S.M Kirov, chair of Obstetrics and Gynecology	St.Petersburg
Russian Federation	Russian Scientific Research Center of Radiology and Surgical Technologies	St.Petersburg
Russian Federation	Saint-Petersburg City Alexandrovsky Hospital	St.Petersburg
Russian Federation	Scientific Research Institute of Obstetrics and Gynecology n.a. D.O.Ott of RAMS	St.Petersburg
Ukraine	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

Sponsors (1)

Lead Sponsor	Collaborator
PregLem SA

Countries where clinical trial is conducted

Czech Republic,  Hungary,  India,  Romania,  Russian Federation,  Ukraine, 

References & Publications (1)

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.; Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.; A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.; Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.; The week 13 PBAC score was calculated using the last 28 days of treatment.	Week 13 visit	No
Primary	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)	Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes.	Week 13	No