PGL4001 Versus GnRH-agonist in Uterine Myomas (PEARLII)
This study has been completed.
Sponsor:
PregLem SA
Information provided by (Responsible Party):
PregLem SA
ClinicalTrials.gov Identifier:
NCT00740831
First received: August 22, 2008
Last updated: December 13, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Myomas |
Drug: PGL4001 Drug: leuprorelin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by PregLem SA:
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) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 13 visit ] [ Designated as safety issue: Yes ]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 [ Time Frame: Up to week 17 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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).
| Enrollment: | 301 |
| Study Start Date: | August 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A (PGL4001 5 mg)
Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
|
Drug: PGL4001
tablets
Other Name: Ulipristal acetate
|
|
Experimental: B (PGL4001 10mg)
Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
|
Drug: PGL4001
tablets
Other Name: Ulipristal acetate
|
|
Active Comparator: C (GnRH-agonist)
PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
|
Drug: leuprorelin
solution for injection
Other Name: GnRH-agonist
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740831
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Hide Study LocationsLocations
| Austria | |
| Medical University Graz | |
| Graz, Austria, 8036 | |
| Medical University of Innsbruck | |
| Innsbruck, Austria, 6020 | |
| Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology | |
| Neunkirchen, Austria, 2620 | |
| Medical University Vienna | |
| Vienna, Austria, 1090 | |
| Belgium | |
| Clinique Universitaire St-Luc | |
| Brussels, Belgium, 1200 | |
| Hopital Erasme, Department of Obstetrics and Gynecology, | |
| Brussels, Belgium, 1070 | |
| CHR de la Citadelle | |
| Liège, Belgium, 4000 | |
| Clinique Universitaire de Mont-Godinne | |
| Yvoir, Belgium, 5530 | |
| France | |
| Cabinet de Gynécologie Chirurgicale | |
| Bordeaux, France, 33000 | |
| CHU de Clermont-Ferrand - Polyclinique Gynécologie-Obstétrique | |
| Clermont Ferrand, France, 63058 | |
| Germany | |
| Klinik für Gynäkologie und Geburtshilfe | |
| Chemnitz, Germany | |
| Private Practice | |
| Frankfurt, Germany, 60322 | |
| Medizinische Hochschule Hannover, Frauenklinik, Abt. I für Frauenheilkunde und Geburtshilfe, | |
| Hannover, Germany, 30625 | |
| Universitätsklinikum Köln Klinik und poliklinik für Frauenheilkunde und Geburtshilfe | |
| Köln, Germany, 50931 | |
| Universität zu Lübeck, Klinik für Gynäkologie und Geburtshilfe | |
| Lübeck, Germany, 23538 | |
| Poliklinik fur Frauenheilkunde und Geburtshilfe | |
| Münster, Germany, 48149 | |
| Universitätsklinikum Tübingen | |
| Tübingen, Germany, 72076 | |
| Ammerland-Klinik GmbH Frauenklinik | |
| Westerstede, Germany, 26655 | |
| Israel | |
| Soroka University Medical Center, Division of Obstetrics & Gynecology | |
| Be'er Sheva, Israel, 84101 | |
| Hadassah University Hospital, Mount Scopus | |
| Jerusalem, Israel | |
| Hadassah University Hospital | |
| Jerusalem, Israel, 91120 | |
| Meir Medical Center | |
| Kfar-Saba, Israel | |
| Western Galilee Hospital Nahariya | |
| Nahariya, Israel, 22100 | |
| Rabin Medical Center, Helen Schneider Hospital for Women | |
| Petach Tikva, Israel, 49100 | |
| Italy | |
| Clinica Ostetrica e Ginecologica II - Università degli Studi di Bari | |
| Bari, Italy | |
| Clinica Obstetrica - Azienda Ospedaliera Universitaria di Cagliari | |
| Cagliari, Italy | |
| Azienda Ospedaliera S. Gerardo - U. O. Ostetricia e Ginecologia | |
| Monza, Italy | |
| Policlinico Universitario Federico II | |
| Napoli, Italy | |
| Universita di Padova-Dip scienze ginecologiche e della riproduzione umana | |
| Padova, Italy | |
| Clinica Ostetrica e Ginecologica - A. O. U. Policlinico Paolo Giaccone | |
| Palermo, Italy, 70100 | |
| Policlinico Universitario "Agostino Gemelli" | |
| Roma, Italy, 00168 | |
| Netherlands | |
| University Medical Center Utrecht, Gynecologist Reproductive Medicine and Surgery, Division for Reproductive Medicine | |
| Utrecht, Netherlands, 3584 CX | |
| Poland | |
| Prywatna Klinika Polozniczo-Ginekologiczna | |
| Bialystok, Poland, 15-224 | |
| INVICTA Sp. Z o.o. | |
| Gdańsk, Poland, 80-895 | |
| Private Practice | |
| Katowice, Poland, 40-084 | |
| Samodzielny Publiczny Szpital Klinika Ginekologii Onkologicznej i Ginekologii | |
| Lublin, Poland, 20-081 | |
| Gabinet Lekarski Specjalistyczny "Sonus" | |
| Warszawa, Poland, 02-066 | |
| Spain | |
| Hospital Clínic i Provincial | |
| Barcelona, Spain, 08036 | |
| Hospital Universitario Vall d'Hebrón | |
| Barcelona, Spain, 08035 | |
| Institut Universitari Dexeus | |
| Barcelona, Spain, 08028 | |
| Clínica Ginecológica CEOGA | |
| Lugo, Spain, 27002 | |
| Hospital Universitario Doce de Octubre | |
| Madrid, Spain, 28041 | |
| Private Practice | |
| Madrid, Spain, 28009 | |
| Hospital Virgen de la Arrixaca Servicio de Ginecología Carretera Madrid-Cartagena | |
| Murcia, Spain, 30120 | |
| Hospital Universitario Dr. Peset | |
| Valencia, Spain, 46017 | |
| Hospital Universitaris La Fe | |
| Valencia, Spain, 46009 | |
Sponsors and Collaborators
PregLem SA
Investigators
| Study Director: | Dr Elke Bestel | PregLem SA |
More Information
Publications:
| Responsible Party: | PregLem SA |
| ClinicalTrials.gov Identifier: | NCT00740831 History of Changes |
| Other Study ID Numbers: | PGL07-022 |
| Study First Received: | August 22, 2008 |
| Results First Received: | July 26, 2012 |
| Last Updated: | December 13, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board Austria: Agency for Health and Food Safety Austria: Ethikkommission Italy: Ethics Committee Spain: Comité Ético de Investigación Clínica Spain: Spanish Agency of Medicines Israel: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Poland: Ministry of Health Netherlands: Medicines Evaluation Board (MEB) |
Keywords provided by PregLem SA:
|
Uterine Myomas |
Additional relevant MeSH terms:
|
Myoma Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases Deslorelin Triptorelin Leuprolide Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents Fertility Agents, Female Fertility Agents |
ClinicalTrials.gov processed this record on May 23, 2013