- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01629563
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIV)
A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Brussels, Belgium, 1200
- Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique
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Leuven, Belgium, 3000
- UZ Leuven campus Gasthuisberg
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Liège, Belgium, 4000
- CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique
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Yvoir, Belgium, 5530
- CHU Mont-Godinne
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Brno, Czechia, 60200
- Centrum ambulantni gynekologie a primarni pece
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Brno, Czechia, 62500
- FN Brno Gynekologicko - porodnická klinika
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Hradec Kralove, Czechia, 50002
- Sanatorium SANUS
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Jihlava, Czechia, 58633
- Nemocnice Jihlava Gynekologicko - porodnicke oddeleni
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Olomouc, Czechia, 77200
- G-CENTRUM Olomouc s.r.o.
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Olomouc, Czechia, 77220
- FN Olomouc, Porodnicko-Gynekologicka klinika
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Praha 3, Czechia, 13000
- Femina Sana, s.r.o.
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Le Kremlin Bicêtre, France, 94275
- Hopital Bicêtre - APHP
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Paris, France, 75018
- Hôpital Bichat, Service de Gynécologie Obstétrique
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Tours, France, 37044
- CHU Bretonneau Service de Gynécologie Obstétrique
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Hamburg, Germany, 22159
- Private Practice
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Hamburg, Germany, 22359
- Private Practice
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Hannover, Germany, 30625
- Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe
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Hessen, Germany, 60322
- Frauenarztpraxis
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Magdeburg, Germany, 39112
- Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung
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München, Germany, 81675
- Technische Universität München
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Bekescsaba, Hungary, 5600
- Rethy Pal Korhaz és Rendelointezet Szuleszeti es Nogyogyaszati Osztaly
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Budapest, Hungary, 1135
- Institution Robert Karoly Maganklinika
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Debrecen, Hungary, 4024
- Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo
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Nyiregyhaza, Hungary, 4400
- Jósa András Oktatókórház
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Szekesfehervar, Hungary, 8000
- Fejer Megyei Szent Gyorgy Korhaz Szuleszeti es Nogyogyaszati Osztaly
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Szentes, Hungary, 6600
- Szuleszeti es Nogyogyaszati Osztaly
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Szolnok, Hungary, 5000
- Sandor Dent Bt.
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Catanzaro, Italy, 88100
- Dipartimento di Ostetricia e Ginecologia, Università degli Studi di Catanzaro "Magna Graecia"
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Roma, Italy, 00168
- Policlinico Universitario "Agostino Gemelli"
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Riga, Latvia, 1001
- Riga 1. hospital
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Riga, Latvia, LV-1005
- Latvian Medical Marine Center
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Riga, Latvia, LV-1010
- Medical Company "ARS"
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Kaunas, Lithuania, 49449
- Saules family medicine center
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Vilnius, Lithuania, 01118
- Family Medicine Centre"Seimos Gydytojas"
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Vilnius, Lithuania, 03225
- Private Clinic "Maxmeda"
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Vilnius, Lithuania, 05263
- Private Clinic "Kardiolita"
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Bucuresti, Romania, 011025
- Centrul Medical SANA SRL
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Bucuresti, Romania, 011426
- Quantum Medical Center SRL Obstetrica-Ginecologie
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Bucuresti, Romania, 012064
- Fortis Medical Center SRL Obstetrica Ginecologie
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Bucuresti, Romania, 020475
- Spitalul Clinic Dr. I.Cantacuzino sectia Obstetrica-Ginecologie
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Bucuresti, Romania, 020762
- Centrul Medical EUROMED SRL, Departamentul de Obtetrica/Ginecologie
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Iasi, Romania, 700398
- Spitalul Clinic de Obstetrica
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Kharkiv, Ukraine, 61176
- Kharkiv City Perinatal Center Gynaecological Department #1
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Odessa, Ukraine, 65039
- Municipal Institution "Maternity Hospital #1" City Center of family planning
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Zaporizhzhya, Ukraine, 69065
- Maternity Hospital#4 Department of Gynaecology
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Edinburgh, United Kingdom, EH16 4TJ
- MRC Centre for Reproductive Health University of Edinburgh
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London, United Kingdom, N18 1QX
- North Middlesex University Hospital NHS Trust
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Newcastle upon Tyne, United Kingdom, NE1 4LP
- Women's Health, Royal Victoria Infirmary
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Norwich, United Kingdom, NR47UY
- Norfolk & Norwich University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be a pre-menopausal woman between 18 and 50 years inclusive.
- Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
- Have FSH levels ≤ 20 mIU/mL
- Have excessive uterine bleeding due to myoma.
- Have regular menstrual cycles
- Have a myomatous uterus < 16 weeks with at least one myoma ≥ 3 cm in diameter.
- If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
Exclusion Criteria:
- Has a history of or current uterine, cervical, ovarian or breast cancer.
- Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
- Has a known severe coagulation disorder.
- Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM).
- Has abnormal hepatic function at study entry.
- Has a positive pregnancy test, 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Ulipristal acetate (PGL4001) 5mg
All subjects will be asked to take a 150mg size tablet (PGL4001 5mg or matching placebo: placebo 5) orally daily for repeated periods 84 days.
The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 150mg size), for 84 days.
The following three treatment courses should be started in the first two days of a menstrual period.
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PGL4001 5 mg daily administration
Other Names:
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Experimental: Ulipristal acetate (PGL4001) 10mg
All subjects will be asked to take a 300mg size tablet (PGL4001 10mg or matching placebo: placebo 10 ) orally daily for repeated periods 84 days.
The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 300mg size), for 84 days.
The following three treatment courses should be started in the first two days of a menstrual period.
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PGL4001 10mg daily administration
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses
Time Frame: 18 months study duration per subject (4 3-month intermittent treatment courses)
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Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval.
Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days.
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18 months study duration per subject (4 3-month intermittent treatment courses)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4
Time Frame: After 18 months
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Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval.
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After 18 months
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Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses
Time Frame: After 18 months
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Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding during the last 56 days of a treatment course. Subjects need to be in controlled bleeding at the end of all 4 treatment courses i.e. for at least 4x56 days. |
After 18 months
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Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids
Time Frame: After 18 months
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For the 3 largest myomas at baseline and the 3 largest myomas at the end of treatment course 4 identified by transvaginal ultrasound, length, height and depth were measured and the volume was estimated by applying the equation for the voulme of an ellipsoid (length x height x depht x π/6). Subjects were exposed to 4 3-month intermittent courses. |
After 18 months
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Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)
Time Frame: After 18 months
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Quality of Life was assessed using a validated questionnaire measuring uterine fibroid symptom severity (UFSQoL) where lower scores indicate fewer symtoms and where a level of 23 has been reported for healthy subject (scale 0-100). Subjects were exposed to 4 3-month intermittent courses. |
After 18 months
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Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)
Time Frame: 18 months
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Quality of Life was measured using a validated uterine fibroid symptom questionnaire. Total score for health related quality of Life (HRQL) range from 0 to 100 with higher scores indicating better Quality of Life. Subjects were exposed to 4 3-month intermittent courses. |
18 months
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Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS)
Time Frame: After 18 months
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Pain was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 with higher score indicating more severe pain. Subjects were exposed to 4 3-month intermittent courses. |
After 18 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pablo Arrigada, MD, PregLem SA
Publications and helpful links
General Publications
- Donnez J, Donnez O, Matule D, Ahrendt HJ, Hudecek R, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Loumaye E. Long-term medical management of uterine fibroids with ulipristal acetate. Fertil Steril. 2016 Jan;105(1):165-173.e4. doi: 10.1016/j.fertnstert.2015.09.032. Epub 2015 Oct 23.
- Donnez J, Hudecek R, Donnez O, Matule D, Arhendt HJ, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Terrill P, Osterloh I, Loumaye E. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015 Feb;103(2):519-27.e3. doi: 10.1016/j.fertnstert.2014.10.038. Epub 2014 Dec 24.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Connective Tissue Diseases
- Neoplasms, Connective Tissue
- Neoplasms, Muscle Tissue
- Leiomyoma
- Myofibroma
- Physiological Effects of Drugs
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Ulipristal acetate
Other Study ID Numbers
- PGL11-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Uterine Fibroids
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Trieu, Nguyen Thi, M.D.Completed
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Elizabeth A. StewartCompletedUterine Fibroids | Myomas | Uterine Leiomyomas | FibroidsUnited States
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Acessa Health, Inc.Active, not recruiting
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Mayo ClinicEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedUterine Fibroids | Myomas | Fibroids | Symptomatic Uterine LeiomyomasUnited States
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InSightecTerminatedUterine Fibroids, With Unexplained InfertilityUnited States
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AbbVieEnrolling by invitation
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Mirabilis Medica, Inc.CompletedUterine Fibroids (Leiomyomas)Mexico
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Suzhou Kintor Pharmaceutical Inc,Completed
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Laboratorios Andromaco S.A.Completed
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PregLem SACompletedUterine FibroidsBelgium, Poland, Austria, Spain
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GSNOR Therapeutics, Inc.UnknownChronic Obstructive Pulmonary Disease (COPD)