PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)

NCT01252069 | Completed Phase 3 DMC

• 1 other identifier: PGL09-027
• Study Type: interventional
• Target: 132
• Locations: 4 countries
• Sites: 18

Brief Summary

This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment. This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

• percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received

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

Study Arms (2)

A

EXPERIMENTAL

PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ended by a drug free period until return of menses.

Drug: PGL4001, placebo, drug free period

B

EXPERIMENTAL

PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets) during 3 periods each ended by a drug free period until return of menses.

Drug: PGL4001, progestin, drug free period

Interventions

PGL4001, placebo, drug free period DRUG

PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ending with a drug free period until return of menses.

Also known as: Ulipristal acetate

A

PGL4001, progestin, drug free period 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) during 3 periods each ending with a drug free period until return of menses.

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 completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.

You may not qualify if:

• Subject has a large uterine polyp (\> 2cm).
• Subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during PGL09-026 study.
• Subject has abnormal hepatic function at re-test.
• Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or interfere with study evaluations.
• Subject has a positive pregnancy test or is planning a pregnancy during the course of the study.

Sponsors & Collaborators

• PregLem SA: lead

Study Sites (18)

Medical University Vienna, department of obstetrics and gynecology

Vienna, 1090, Austria

Location

Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique

Brussels, 1200, Belgium

Location

CHR de la Citadelle Gynécologie-Obstétrique

Liège, 4000, Belgium

Location

Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique

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

Hospital Universitario Hebron, gynecology department

Barcelona, 08035, Spain

Location

Clinica Ginecologica CEOGA, departamento de Ginecologia

Lugo, 27002, Spain

Location

Private Practice

Madrid, 28009, Spain

Location

HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre Departamento de Ginecología

Madrid, 28041, Spain

Location

CHIP (Complejo Hospitalario Integral Privado)

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: November 30, 2010
• First Posted: December 2, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

ES (5); AU (1); PL (9); BE (3)