PGL4001 Versus Placebo in Uterine Myomas

NCT00755755 | Completed Phase 3 Results DMC

• 1 other identifier: PGL07-021
• Study Type: interventional
• Target: 241
• Locations: 6 countries
• Sites: 38

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.

Conditions

Uterine Myomas

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Week 13 visit

• 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)

  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.

  Week 13

Study Arms (3)

A (PGL4001 5mg)

EXPERIMENTAL

PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+

Drug: PGL4001 (ulipristal) and iron

B (PGL4001 10mg)

EXPERIMENTAL

PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+

Drug: PGL4001 (ulipristal) and iron

C (placebo)

PLACEBO COMPARATOR

PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+

Drug: PGL4001 matching placebo and iron

Interventions

PGL4001 (ulipristal) and iron DRUG

tablets

Also known as: Ulipristal acetate

A (PGL4001 5mg)

PGL4001 matching placebo and iron DRUG

tablets

Also known as: Placebo of ulipristal

C (placebo)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PregLem SA: lead

Study Sites (38)

Gynekologicko-porodnicka klinika FN Brno

Brno, 625 00, Czechia

Location

Mediva

Prague, 110 00, Czechia

Location

Gynekologicko-porodnicka klinika 1.LF UK a VFN

Prague, 128 00, Czechia

Location

Gynekologicko-porodnicka klinika UK 2.LF a FN

Prague, 150 06, Czechia

Location

Rethy-Pal Hospital-Clinic Bekescsaba, Department of Obstetrics and Gynecology

Békéscsaba, 5600, Hungary

Location

Saint Stephen Hospital of Budapest,Department of Obstetrics, Gynecology and Gynecological Oncology

Budapest, 1096, Hungary

Location

Fovarosi Bajcsy-Zsilinszky Hospital, Department of Obstetrics and Gynecology

Budapest, 1106, Hungary

Location

Dr. Bugyi Istvan Hospital, Department of Obstetrics and Gynecology

Szentes, 6600, Hungary

Location

Saint George Hospital of Fejer County, Department of Obstetrics and Gynecology

Székesfehérvár, 8000, Hungary

Location

Saint Borbala Hospital of Komarom-Esztergom County, Department of Obstetrics and Gynecology

Tatabánya, 2800, Hungary

Location

Dr. Jilla Hospital

Aurangabad, 431001, India

Location

M. S. Ramaiah Medical College and Memorial Hospital

Bangalore, 560054, India

Location

Divakars Speciality Hospital

Bangalore, 560078, India

Location

Sri Ramachandra Medical College and Research Institute

Chennai, 600116, India

Location

Om Women's Hospital

Nagpur, 440010, India

Location

Nagpur Test Tube Baby Centre

Nagpur, 440022, India

Location

Central Medical Sanador

Bucharest, 011026, Romania

Location

Departamentul de Obstretica Ginecologie si Nou Nascuti

Bucharest, 020395, Romania

Location

Centrul Medical Euromed, departementul de Obstetrica/Ginecologie

Bucharest, 020762, Romania

Location

Sectia Obstretica-Ginecologie Spitalul Clinic Dr. Ioan Cantacuzino

Bucharest, 70266, Romania

Location

Spitalul Clinic de Obstetrica Ginecologie Oradea

Oradea, 410053, Romania

Location

Spitalul Clinic Judetean de urgenta, sectia de obstetrica Ginecologie I

Târgu Mureş, 540136, Romania

Location

Northern State Medical University

Arkhangelsk, 163001, Russia

Location

Kursk State Medical University

Kursk, 305035, Russia

Location

American Medical Clinic

Saint Petersburg, 190000, Russia

Location

Saint-Petersburg City Alexandrovsky Hospital

Saint Petersburg, 193312, Russia

Location

Military Medical Academy n.a.S.M Kirov, chair of Obstetrics and Gynecology

Saint Petersburg, 194044, Russia

Location

Medical Research Institute (MRI)

Saint Petersburg, 196084, Russia

Location

Russian Scientific Research Center of Radiology and Surgical Technologies

Saint Petersburg, 197758, Russia

Location

Scientific Research Institute of Obstetrics and Gynecology n.a. D.O.Ott of RAMS

Saint Petersburg, 199034, Russia

Location

OAO "Medical company IDK"

Samara, 443067, Russia

Location

Donetsk National Medical University, Department of Obstetrics, Gynecology and Perinatology FPE

Donetsk, Ukraine

Location

City Clinical Hospital N9

Kiev, 04112, Ukraine

Location

Institute of Pediatrics, Obstetrics and Gynecology, Department of Endocrine Gynecology

Kiev, Ukraine

Location

Kiev Maternity Hospital No.2

Kiev, Ukraine

Location

State Enterprise "Institute of Pediatrics, Obstetrics and Gynecology of AMS of Ukraine

Kyiv, Ukraine

Location

Lviv National Medical University named after Danylo Halytskyy

Lviv, 79032, Ukraine

Location

Medical Sanitory Centre VAT "Motor Sich" Gynecology department

Zaporizhzhya, Ukraine

Location

Related Publications (2)

• Donnez J, Tatarchuk TF, Bouchard P, Puscasiu L, Zakharenko NF, Ivanova T, Ugocsai G, Mara M, Jilla MP, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL I Study Group. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012 Feb 2;366(5):409-20. doi: 10.1056/NEJMoa1103182.

  PMID: 22296075 RESULT

• Barlow DH, Lumsden MA, Fauser BC, Terrill P, Bestel E. Individualized vaginal bleeding experience of women with uterine fibroids in the PEARL I randomized controlled trial comparing the effects of ulipristal acetate or placebo. Hum Reprod. 2014 Mar;29(3):480-9. doi: 10.1093/humrep/det467. Epub 2014 Jan 23.

  PMID: 24457604 DERIVED

MeSH Terms

Interventions

ulipristal; Iron; ulipristal acetate

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Results Point of Contact

• Title: Dr Elke Bestel
• Organization: PregLem S.A.

medical@preglem.com

+41 22 884 03 40

Study Officials

• Dr Elke Bestel

  PregLem SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 19, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 13, 2012
• Results First Posted: November 16, 2012

Record last verified: 2012-12

Locations

UA (7); CZ (4); RO (6); RU (9); HU (6); IN (6)