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

Phase 3

Completed

• Conditions: Uterine Fibroids
• Interventions: Drug: PGL4001, progestin, drug free period; Drug: PGL4001, placebo, drug free period

• Registration Number: NCT01252069
• Lead Sponsor: PregLem SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-02
• Study Start: 2011-01
• Primary Completion: 2013-08
• Study Completion: 2014-01
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	PGL4001, progestin, drug free period	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.
A	PGL4001, placebo, drug free period	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.

Primary Outcome Measures

Name	Time	Method
percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received	From baseline to end of each PGL4001 treatment (3months treatment)

Trial Locations

Locations (15)

Medical University Vienna, department of obstetrics and gynecology; 🇦🇹 Vienna, Austria

Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique; 🇧🇪 Bruxelles, Belgium

CHR de la Citadelle Gynécologie-Obstétrique; 🇧🇪 Liège, Belgium

Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique; 🇧🇪 Yvoir, Belgium

Private practice; 🇵🇱 Warszawa, Poland

Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej; 🇵🇱 Warszawa, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa; 🇵🇱 Wroclaw, Poland

Prywatna Klinika Polozniczo-Ginekologiczna; 🇵🇱 Bialystok, Poland

INVICTA Sp. Z o.o.; 🇵🇱 Gdańsk, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii; 🇵🇱 Lublin, Poland

Private Practice; 🇪🇸 Madrid, Spain

CHIP (Complejo Hospitalario Integral Privado); 🇪🇸 Malaga, Spain

Hospital Universitario Hebron, gynecology department; 🇪🇸 Barcelona, Spain

Clinica Ginecologica CEOGA, departamento de Ginecologia; 🇪🇸 Lugo, Spain

HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre Departamento de Ginecología; 🇪🇸 Madrid, Spain