PGL4001 Versus GnRH-agonist in Uterine Myomas
- Registration Number
- NCT00740831
- Lead Sponsor
- PregLem SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 301
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A (PGL4001 5 mg) PGL4001 Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection) B (PGL4001 10mg) PGL4001 Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection) C (GnRH-agonist) leuprorelin PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
- Primary Outcome Measures
Name Time Method 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) 3 months 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 Week 13 visit 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 Up to week 17 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
Name Time Method Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13 3 months 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).
Trial Locations
- Locations (44)
Hospital Universitario Vall d'Hebrón
🇪🇸Barcelona, Spain
Clinica Obstetrica - Azienda Ospedaliera Universitaria di Cagliari
🇮🇹Cagliari, Italy
Policlinico Universitario Federico II
🇮🇹Napoli, Italy
Hospital Universitaris La Fe
🇪🇸Valencia, Spain
Hospital Virgen de la Arrixaca Servicio de Ginecología Carretera Madrid-Cartagena
🇪🇸Murcia, Spain
Hospital Universitario Dr. Peset
🇪🇸Valencia, Spain
Azienda Ospedaliera S. Gerardo - U. O. Ostetricia e Ginecologia
🇮🇹Monza, Italy
Prywatna Klinika Polozniczo-Ginekologiczna
🇵🇱Bialystok, Poland
INVICTA Sp. Z o.o.
🇵🇱Gdańsk, Poland
Policlinico Universitario "Agostino Gemelli"
🇮🇹Roma, Italy
Institut Universitari Dexeus
🇪🇸Barcelona, Spain
Clinica Ostetrica e Ginecologica - A. O. U. Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Cabinet de Gynécologie Chirurgicale
🇫🇷Bordeaux, France
Universita di Padova-Dip scienze ginecologiche e della riproduzione umana
🇮🇹Padova, Italy
Hospital Clínic i Provincial
🇪🇸Barcelona, Spain
Clínica Ginecológica CEOGA
🇪🇸Lugo, Spain
Samodzielny Publiczny Szpital Klinika Ginekologii Onkologicznej i Ginekologii
🇵🇱Lublin, Poland
Gabinet Lekarski Specjalistyczny "Sonus"
🇵🇱Warszawa, Poland
Medical University Graz
🇦🇹Graz, Austria
CHU de Clermont-Ferrand - Polyclinique Gynécologie-Obstétrique
🇫🇷Clermont Ferrand, France
Private Practice
🇪🇸Madrid, Spain
Medizinische Hochschule Hannover, Frauenklinik, Abt. I für Frauenheilkunde und Geburtshilfe,
🇩🇪Hannover, Germany
Universitätsklinikum Köln Klinik und poliklinik für Frauenheilkunde und Geburtshilfe
🇩🇪Köln, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Universität zu Lübeck, Klinik für Gynäkologie und Geburtshilfe
🇩🇪Lübeck, Germany
Hadassah University Hospital
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kfar-Saba, Israel
Poliklinik fur Frauenheilkunde und Geburtshilfe
🇩🇪Münster, Germany
Soroka University Medical Center, Division of Obstetrics & Gynecology
🇮🇱Be'er Sheva, Israel
Western Galilee Hospital Nahariya
🇮🇱Nahariya, Israel
Rabin Medical Center, Helen Schneider Hospital for Women
🇮🇱Petach Tikva, Israel
Ammerland-Klinik GmbH Frauenklinik
🇩🇪Westerstede, Germany
Clinica Ostetrica e Ginecologica II - Università degli Studi di Bari
🇮🇹Bari, Italy
Hadassah University Hospital, Mount Scopus
🇮🇱Jerusalem, Israel
Hospital Universitario Doce de Octubre
🇪🇸Madrid, Spain
Klinik für Gynäkologie und Geburtshilfe
🇩🇪Chemnitz, Germany
Medical University of Innsbruck
🇦🇹Innsbruck, Austria
CHR de la Citadelle
🇧🇪Liège, Belgium
Medical University Vienna
🇦🇹Vienna, Austria
Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology
🇦🇹Neunkirchen, Austria
Clinique Universitaire St-Luc
🇧🇪Brussels, Belgium
University Medical Center Utrecht, Gynecologist Reproductive Medicine and Surgery, Division for Reproductive Medicine
🇳🇱Utrecht, Netherlands
Hopital Erasme, Department of Obstetrics and Gynecology,
🇧🇪Brussels, Belgium
Clinique Universitaire de Mont-Godinne
🇧🇪Yvoir, Belgium