Back to resultsPGL4001 Versus GnRH-agonist in Uterine Myomas (PEARLII)
Primary Purpose
Uterine Myomas
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PGL4001
leuprorelin
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Myomas focused on measuring Uterine Myomas
Eligibility Criteria
Inclusion Criteria:
- Be a pre-menopausal woman between 18 and 50 years inclusive.
- Have excessive uterine bleeding due to myoma
- 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 or adenocarcinoma.
- 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 a history of or known current osteoporosis.
- 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.
Sites / Locations
- Medical University Graz
- Medical University of Innsbruck
- Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology
- Medical University Vienna
- Hopital Erasme, Department of Obstetrics and Gynecology,
- Clinique Universitaire St-Luc
- CHR de la Citadelle
- Clinique Universitaire de Mont-Godinne
- Cabinet de Gynécologie Chirurgicale
- CHU de Clermont-Ferrand - Polyclinique Gynécologie-Obstétrique
- Klinik für Gynäkologie und Geburtshilfe
- Private Practice
- Medizinische Hochschule Hannover, Frauenklinik, Abt. I für Frauenheilkunde und Geburtshilfe,
- Universitätsklinikum Köln Klinik und poliklinik für Frauenheilkunde und Geburtshilfe
- Universität zu Lübeck, Klinik für Gynäkologie und Geburtshilfe
- Poliklinik fur Frauenheilkunde und Geburtshilfe
- Universitätsklinikum Tübingen
- Ammerland-Klinik GmbH Frauenklinik
- Soroka University Medical Center, Division of Obstetrics & Gynecology
- Hadassah University Hospital
- Hadassah University Hospital, Mount Scopus
- Meir Medical Center
- Western Galilee Hospital Nahariya
- Rabin Medical Center, Helen Schneider Hospital for Women
- Clinica Ostetrica e Ginecologica II - Università degli Studi di Bari
- Clinica Obstetrica - Azienda Ospedaliera Universitaria di Cagliari
- Azienda Ospedaliera S. Gerardo - U. O. Ostetricia e Ginecologia
- Policlinico Universitario Federico II
- Universita di Padova-Dip scienze ginecologiche e della riproduzione umana
- Clinica Ostetrica e Ginecologica - A. O. U. Policlinico Paolo Giaccone
- Policlinico Universitario "Agostino Gemelli"
- University Medical Center Utrecht, Gynecologist Reproductive Medicine and Surgery, Division for Reproductive Medicine
- Prywatna Klinika Polozniczo-Ginekologiczna
- INVICTA Sp. Z o.o.
- Private Practice
- Samodzielny Publiczny Szpital Klinika Ginekologii Onkologicznej i Ginekologii
- Gabinet Lekarski Specjalistyczny "Sonus"
- Institut Universitari Dexeus
- Hospital Universitario Vall d'Hebrón
- Hospital Clínic i Provincial
- Clínica Ginecológica CEOGA
- Private Practice
- Hospital Universitario Doce de Octubre
- Hospital Virgen de la Arrixaca Servicio de Ginecología Carretera Madrid-Cartagena
- Hospital Universitaris La Fe
- Hospital Universitario Dr. Peset
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
A (PGL4001 5 mg)
B (PGL4001 10mg)
C (GnRH-agonist)
Arm Description
Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
Outcomes
Primary Outcome Measures
Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)
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.
Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist
Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples
Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist
Difference in percentage of subjects reporting moderate or severe hot flushes:
Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17.
Secondary Outcome Measures
Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13
Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.
The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00740831
Brief Title
PGL4001 Versus GnRH-agonist in Uterine Myomas
Acronym
PEARLII
Official Title
A Phase III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PregLem SA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Myomas
Keywords
Uterine Myomas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
301 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A (PGL4001 5 mg)
Arm Type
Experimental
Arm Description
Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
Arm Title
B (PGL4001 10mg)
Arm Type
Experimental
Arm Description
Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
Arm Title
C (GnRH-agonist)
Arm Type
Active Comparator
Arm Description
PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
Intervention Type
Drug
Intervention Name(s)
PGL4001
Other Intervention Name(s)
Ulipristal acetate
Intervention Description
tablets
Intervention Type
Drug
Intervention Name(s)
leuprorelin
Other Intervention Name(s)
GnRH-agonist
Intervention Description
solution for injection
Primary Outcome Measure Information:
Title
Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)
Description
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.
Time Frame
3 months
Title
Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist
Description
Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples
Time Frame
Week 13 visit
Title
Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist
Description
Difference in percentage of subjects reporting moderate or severe hot flushes:
Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17.
Time Frame
Up to week 17
Secondary Outcome Measure Information:
Title
Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13
Description
Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.
The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10).
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be a pre-menopausal woman between 18 and 50 years inclusive.
Have excessive uterine bleeding due to myoma
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 or adenocarcinoma.
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 a history of or known current osteoporosis.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Elke Bestel
Organizational Affiliation
PregLem SA
Official's Role
Study Director
Facility Information:
Facility Name
Medical University Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medical University of Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology
City
Neunkirchen
ZIP/Postal Code
2620
Country
Austria
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hopital Erasme, Department of Obstetrics and Gynecology,
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Clinique Universitaire St-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clinique Universitaire de Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Cabinet de Gynécologie Chirurgicale
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU de Clermont-Ferrand - Polyclinique Gynécologie-Obstétrique
City
Clermont Ferrand
ZIP/Postal Code
63058
Country
France
Facility Name
Klinik für Gynäkologie und Geburtshilfe
City
Chemnitz
Country
Germany
Facility Name
Private Practice
City
Frankfurt
ZIP/Postal Code
60322
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Frauenklinik, Abt. I für Frauenheilkunde und Geburtshilfe,
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Köln Klinik und poliklinik für Frauenheilkunde und Geburtshilfe
City
Köln
ZIP/Postal Code
50931
Country
Germany
Facility Name
Universität zu Lübeck, Klinik für Gynäkologie und Geburtshilfe
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Poliklinik fur Frauenheilkunde und Geburtshilfe
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Ammerland-Klinik GmbH Frauenklinik
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Soroka University Medical Center, Division of Obstetrics & Gynecology
City
Be'er Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Hadassah University Hospital, Mount Scopus
City
Jerusalem
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
Country
Israel
Facility Name
Western Galilee Hospital Nahariya
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Rabin Medical Center, Helen Schneider Hospital for Women
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Clinica Ostetrica e Ginecologica II - Università degli Studi di Bari
City
Bari
Country
Italy
Facility Name
Clinica Obstetrica - Azienda Ospedaliera Universitaria di Cagliari
City
Cagliari
Country
Italy
Facility Name
Azienda Ospedaliera S. Gerardo - U. O. Ostetricia e Ginecologia
City
Monza
Country
Italy
Facility Name
Policlinico Universitario Federico II
City
Napoli
Country
Italy
Facility Name
Universita di Padova-Dip scienze ginecologiche e della riproduzione umana
City
Padova
Country
Italy
Facility Name
Clinica Ostetrica e Ginecologica - A. O. U. Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
70100
Country
Italy
Facility Name
Policlinico Universitario "Agostino Gemelli"
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
University Medical Center Utrecht, Gynecologist Reproductive Medicine and Surgery, Division for Reproductive Medicine
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Prywatna Klinika Polozniczo-Ginekologiczna
City
Bialystok
ZIP/Postal Code
15-224
Country
Poland
Facility Name
INVICTA Sp. Z o.o.
City
Gdańsk
ZIP/Postal Code
80-895
Country
Poland
Facility Name
Private Practice
City
Katowice
ZIP/Postal Code
40-084
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Klinika Ginekologii Onkologicznej i Ginekologii
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Gabinet Lekarski Specjalistyczny "Sonus"
City
Warszawa
ZIP/Postal Code
02-066
Country
Poland
Facility Name
Institut Universitari Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic i Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Clínica Ginecológica CEOGA
City
Lugo
ZIP/Postal Code
27002
Country
Spain
Facility Name
Private Practice
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario Doce de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca Servicio de Ginecología Carretera Madrid-Cartagena
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitaris La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
22296076
Citation
Donnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180.
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PGL4001 Versus GnRH-agonist in Uterine Myomas
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