PGL4001 Versus Placebo in Uterine Myomas

Phase 3

Completed

• Conditions: Uterine Myomas
• Interventions: Drug: PGL4001 matching placebo and iron; Drug: PGL4001 (ulipristal) and iron

• Registration Number: NCT00755755
• Lead Sponsor: PregLem SA

Brief Summary

This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, 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

Study Timeline

• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-18
• Study First Posted: 2008-09-19
• Study Start: 2008-10
• Primary Completion: 2010-03
• Study Completion: 2010-08
• Results First Submitted: 2012-07-26
• Results First Submitted QC: 2012-10-16
• Results First Posted: 2012-11-16
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-11
• Last Update Posted: 2012-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 241

Inclusion Criteria

• Be a pre-menopausal woman between 18 and 50 years inclusive.
• Have excessive uterine bleeding due to myoma.
• Have a myoma-related anaemia.
• 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.
• 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 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
C (placebo)	PGL4001 matching placebo and iron	PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
A (PGL4001 5mg)	PGL4001 (ulipristal) and iron	PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
B (PGL4001 10mg)	PGL4001 (ulipristal) and iron	PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+

Primary Outcome Measures

Name	Time	Method
Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)	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 Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)	Week 13	Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes.

Trial Locations

Locations (38)

Divakars Speciality Hospital; 🇮🇳 Bangalore, India

Gynekologicko-porodnicka klinika UK 2.LF a FN; 🇨🇿 Praha, Czech Republic

Fovarosi Bajcsy-Zsilinszky Hospital, Department of Obstetrics and Gynecology; 🇭🇺 Budapest, Hungary

Dr. Bugyi Istvan Hospital, Department of Obstetrics and Gynecology; 🇭🇺 Szentes, Hungary

Saint Borbala Hospital of Komarom-Esztergom County, Department of Obstetrics and Gynecology; 🇭🇺 Tatabanya, Hungary

Rethy-Pal Hospital-Clinic Bekescsaba, Department of Obstetrics and Gynecology; 🇭🇺 Bekescsaba, Hungary

Saint Stephen Hospital of Budapest,Department of Obstetrics, Gynecology and Gynecological Oncology; 🇭🇺 Budapest, Hungary

M. S. Ramaiah Medical College and Memorial Hospital; 🇮🇳 Bangalore, India

Gynekologicko-porodnicka klinika 1.LF UK a VFN; 🇨🇿 Praha, Czech Republic

Gynekologicko-porodnicka klinika FN Brno; 🇨🇿 Brno, Czech Republic

Mediva; 🇨🇿 Praha, Czech Republic

Sri Ramachandra Medical College and Research Institute; 🇮🇳 Chennai, India

Nagpur Test Tube Baby Centre; 🇮🇳 Nagpur, India

Om Women's Hospital; 🇮🇳 Nagpur, India

Spitalul Clinic Judetean de urgenta, sectia de obstetrica Ginecologie I; 🇷🇴 Targu Mures, Romania

Northern State Medical University; 🇷🇺 Arkhangelsk, Russian Federation

OAO "Medical company IDK"; 🇷🇺 Samara, Russian Federation

American Medical Clinic; 🇷🇺 St. Petersburg, Russian Federation

Military Medical Academy n.a.S.M Kirov, chair of Obstetrics and Gynecology; 🇷🇺 St.Petersburg, Russian Federation

Medical Research Institute (MRI); 🇷🇺 St.Petersburg, Russian Federation

State Enterprise "Institute of Pediatrics, Obstetrics and Gynecology of AMS of Ukraine; 🇺🇦 Kyiv, Ukraine

Medical Sanitory Centre VAT "Motor Sich" Gynecology department; 🇺🇦 Zaporizhzhya, Ukraine

Central Medical Sanador; 🇷🇴 Bucharest, Romania

City Clinical Hospital N9; 🇺🇦 Kiev, Ukraine

Institute of Pediatrics, Obstetrics and Gynecology, Department of Endocrine Gynecology; 🇺🇦 Kiev, Ukraine

Scientific Research Institute of Obstetrics and Gynecology n.a. D.O.Ott of RAMS; 🇷🇺 St.Petersburg, Russian Federation

Donetsk National Medical University, Department of Obstetrics, Gynecology and Perinatology FPE; 🇺🇦 Donetsk, Ukraine

Kiev Maternity Hospital No.2; 🇺🇦 Kiev, Ukraine

Saint George Hospital of Fejer County, Department of Obstetrics and Gynecology; 🇭🇺 Szekesfehervar, Hungary

Dr. Jilla Hospital; 🇮🇳 Aurangabad, India

Departamentul de Obstretica Ginecologie si Nou Nascuti; 🇷🇴 Bucharest, Romania

Sectia Obstretica-Ginecologie Spitalul Clinic Dr. Ioan Cantacuzino; 🇷🇴 Bucharest, Romania

Spitalul Clinic de Obstetrica Ginecologie Oradea; 🇷🇴 Oradea, Romania

Saint-Petersburg City Alexandrovsky Hospital; 🇷🇺 St.Petersburg, Russian Federation

Centrul Medical Euromed, departementul de Obstetrica/Ginecologie; 🇷🇴 Bucuresti, Romania

Kursk State Medical University; 🇷🇺 Kursk, Russian Federation

Russian Scientific Research Center of Radiology and Surgical Technologies; 🇷🇺 St.Petersburg, Russian Federation

Lviv National Medical University named after Danylo Halytskyy; 🇺🇦 Lviv, Ukraine