PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

NCT01156857 | Completed Phase 3 DMC

• 1 other identifier: PGL09-026
• Study Type: interventional
• Target: 209
• Locations: 4 countries
• Sites: 23

Brief Summary

This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (2)

• Efficacy endpoints

  Investigate efficacy of PGL4001 on uterine bleeding (% of subjects in amenorrhea at end of PGL4001 treatment), myoma size (transvaginal ultrasound), pain (short Mc Gill questionnaire) and quality of life (specific UFS-QoL questionnaire and general EQ-5D questionnaire).

  From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.

• Number and proportion of subjects experiencing open label treatment-emergent adverse events

  From baseline to end of PGL4001 treatment (3months treatment)

Study Arms (2)

A

EXPERIMENTAL

Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).

Drug: PGL4001, placebo

B

EXPERIMENTAL

Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets).

Drug: PGL4001, progestin

Interventions

PGL4001, placebo DRUG

PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).

Also known as: Ulipristal acetate

A

PGL4001, progestin DRUG

PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets).

Also known as: Ulipristal acetate

B

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
• Subject with a Body Mass Index ≥18 and ≤40.
• Subject with myomatous uterus size \< 16 weeks.
• Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.
• Subject complained of strong uterine bleeding.
• Subject is eligible for hysterectomy or myomectomy.
• Females of childbearing potential have to practice a non-hormonal method of contraception.

You may not qualify if:

• Subject has a history of or current uterus, cervix, ovarian or breast cancer.
• Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.
• Subject has a known severe coagulation disorder.
• Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
• Subject has abnormal hepatic function at study entry.

Sponsors & Collaborators

• PregLem SA: lead

Study Sites (23)

Medical University Graz, department of obstetrics and gynecology

Graz, 8047, Austria

Location

Medical University Vienna, department of obstetrics and gynecology

Vienna, 1090, Austria

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

CHR de la citadelle

Liège, 4000, Belgium

Location

Cliniques Universitaires UCL de Mont-Godinne

Yvoir, 5530, Belgium

Location

Prywatna Klinika Polozniczo-Ginekologiczna

Bialystok, 15-224, Poland

Location

INVICTA Sp. Z o.o.

Gdansk, 80-895, Poland

Location

Private Practice

Katowice, 40-724, Poland

Location

Private Practice

Lodz, 90-602, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii

Lublin, 20-081, Poland

Location

Private Practice

Warsaw, 00-815, Poland

Location

Private Practice

Warsaw, 02-066, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej

Warsaw, 02-507, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa

Wroclaw, 50-369, Poland

Location

Institut Universitari Dexeus Departamento de Ginecología

Barcelona, 08028, Spain

Location

Hospital Universitario Hebron, gynecology department

Barcelona, 08035, Spain

Location

Hospital Clinic i provincial de Barcelona, gynecology department

Barcelona, 08036, Spain

Location

Hospital General de Ciudad Real Gynecology

Ciudad Real, 13005, Spain

Location

Hospital Universitario de Guadalajara Consultas de Ginecología (Planta 0)

Guadalajara, 19002, Spain

Location

Clinica Ginecologica CEOGA, departamento de Ginecologia

Lugo, 27002, Spain

Location

Private pratice

Madrid, 28009, Spain

Location

Hospital universitario 12 de Octubre, departamento de ginecologia

Madrid, 28041, Spain

Location

CHIP

Málaga, 29010, Spain

Location

Related Publications (1)

• Donnez J, Vazquez F, Tomaszewski J, Nouri K, Bouchard P, Fauser BC, Barlow DH, Palacios S, Donnez O, Bestel E, Osterloh I, Loumaye E; PEARL III and PEARL III Extension Study Group. Long-term treatment of uterine fibroids with ulipristal acetate ☆. Fertil Steril. 2014 Jun;101(6):1565-73.e1-18. doi: 10.1016/j.fertnstert.2014.02.008. Epub 2014 Mar 12.

  PMID: 24630081 DERIVED

MeSH Terms

Conditions

Leiomyoma

Interventions

ulipristal acetate; Progestins

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

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: July 1, 2010
• First Posted: July 5, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2012
• Last Updated: January 15, 2016

Record last verified: 2013-06

Locations

ES (9); BE (3); PL (9); AU (2)