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

NCT ID: NCT01252069

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

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.

Group Type: EXPERIMENTAL

PGL4001, placebo, drug free period

Intervention Type: 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.

B

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.

Group Type: EXPERIMENTAL

PGL4001, progestin, drug free period

Intervention Type: 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.

Interventions

PGL4001, placebo, drug free period

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.

Intervention Type: DRUG

PGL4001, progestin, drug free period

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.

Intervention Type: DRUG

Other Intervention Names

Ulipristal acetate; Ulipristal acetate

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

PregLem SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University Vienna, department of obstetrics and gynecology

Vienna, , Austria

Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique

Brussels, , Belgium

CHR de la Citadelle Gynécologie-Obstétrique

Liège, , Belgium

Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique

Yvoir, , Belgium

Prywatna Klinika Polozniczo-Ginekologiczna

Bialystok, , Poland

INVICTA Sp. Z o.o.

Gdansk, , Poland

Private practice

Katowice, , Poland

Private practice

Lodz, , Poland

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

Lublin, , Poland

Private Practice

Warsaw, , Poland

Private practice

Warsaw, , Poland

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

Warsaw, , Poland

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

Wroclaw, , Poland

Hospital Universitario Hebron, gynecology department

Barcelona, , Spain

Clinica Ginecologica CEOGA, departamento de Ginecologia

Lugo, , Spain

Private Practice

Madrid, , Spain

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

Madrid, , Spain

CHIP (Complejo Hospitalario Integral Privado)

Málaga, , Spain

Countries

Austria; Belgium; Poland; Spain

References

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.

Reference Type: DERIVED

PMID: 24630081 (View on PubMed)

Other Identifiers

PGL09-027

Identifier Type: -

Identifier Source: org_study_id