PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Uterine Fibroids Clinical Trial

— PEARLIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629563
• Other study ID #: PGL11-006
• Status: Completed
• Phase: Phase 3
• Start date: June 2012
• Est. completion date: January 2015

Study information

• Verified date: August 2019
• Source: PregLem SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.

Description:

The target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• 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 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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• PGL4001 5 mg
PGL4001 5 mg daily administration
• PGL4001 10 mg
PGL4001 10mg daily administration

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique	Brussels
Belgium	UZ Leuven Campus Gasthuisberg	Leuven
Belgium	CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique	Liège
Belgium	CHU Mont-Godinne	Yvoir
Czechia	Centrum ambulantni gynekologie a primarni pece	Brno
Czechia	FN Brno Gynekologicko - porodnická klinika	Brno
Czechia	Sanatorium SANUS	Hradec Kralove
Czechia	Nemocnice Jihlava Gynekologicko - porodnicke oddeleni	Jihlava
Czechia	FN Olomouc, Porodnicko-Gynekologicka klinika	Olomouc
Czechia	G-CENTRUM Olomouc s.r.o.	Olomouc
Czechia	Femina Sana, s.r.o.	Praha 3
France	Hôpital Bicêtre - APHP	Le Kremlin Bicêtre
France	Hôpital Bichat, Service de Gynécologie Obstétrique	Paris
France	CHU Bretonneau Service de Gynécologie Obstétrique	Tours
Germany	Private practice	Hamburg
Germany	Private practice	Hamburg
Germany	Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe	Hannover
Germany	Frauenarztpraxis	Hessen
Germany	Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung	Magdeburg
Germany	Technische Universität München	München
Hungary	Rethy Pal Korhaz és Rendelointezet Szuleszeti es Nogyogyaszati Osztaly	Bekescsaba
Hungary	Institution Robert Karoly Maganklinika	Budapest
Hungary	Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo	Debrecen
Hungary	Josa Andras Oktatokorhaz	Nyiregyhaza
Hungary	Fejer Megyei Szent Gyorgy Korhaz Szuleszeti es Nogyogyaszati Osztaly	Szekesfehervar
Hungary	Szuleszeti es Nogyogyaszati Osztaly	Szentes
Hungary	Sandor Dent Bt.	Szolnok
Italy	Dipartimento di Ostetricia e Ginecologia, Università degli Studi di Catanzaro "Magna Graecia"	Catanzaro
Italy	Policlinico Universitario "Agostino Gemelli"	Roma
Latvia	Latvian Medical Marine Center	Riga
Latvia	Medical Company "ARS"	Riga
Latvia	Riga 1. hospital	Riga
Lithuania	Saules Family Medicine Center	Kaunas
Lithuania	Family Medicine Centre"Seimos Gydytojas"	Vilnius
Lithuania	Private Clinic "Kardiolita"	Vilnius
Lithuania	Private Clinic "Maxmeda"	Vilnius
Romania	Centrul Medical EUROMED SRL, Departamentul de Obtetrica/Ginecologie	Bucuresti
Romania	Centrul Medical SANA SRL	Bucuresti
Romania	Fortis Medical Center SRL Obstetrica Ginecologie	Bucuresti
Romania	Quantum Medical Center SRL Obstetrica-Ginecologie	Bucuresti
Romania	Spitalul Clinic Dr. I.Cantacuzino sectia Obstetrica-Ginecologie	Bucuresti
Romania	Spitalul Clinic de Obstetrica	Iasi
Ukraine	Kharkiv City Perinatal Center Gynaecological Department #1	Kharkiv
Ukraine	Municipal Institution "Maternity Hospital #1" City Center of family planning	Odessa
Ukraine	Maternity Hospital#4 Department of Gynaecology	Zaporizhzhya
United Kingdom	MRC Centre for Reproductive Health University of Edinburgh	Edinburgh
United Kingdom	North Middlesex University Hospital NHS Trust	London
United Kingdom	Women's Health, Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	Norfolk & Norwich University Hospital	Norwich

Sponsors (1)

Lead Sponsor	Collaborator
PregLem SA

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Germany,  Hungary,  Italy,  Latvia,  Lithuania,  Romania,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses	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.	18 months study duration per subject (4 3-month intermittent treatment courses)
Secondary	Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4	Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval.	After 18 months
Secondary	Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses	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
Secondary	Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids	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 p/6).; Subjects were exposed to 4 3-month intermittent courses.	After 18 months
Secondary	Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)	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
Secondary	Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)	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
Secondary	Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS)	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