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

Uterine Fibroids Clinical Trial

Official title:

A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252069
• Other study ID #: PGL09-027
• Status: Completed
• Phase: Phase 3
• First received: November 30, 2010
• Last updated: January 12, 2016
• Start date: January 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2016
• Source: PregLem SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsPoland: Ministry of HealthAustria: Federal Office for Safety in Health CareSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: January 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Austria	Medical University Vienna, department of obstetrics and gynecology	Vienna
Belgium	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
Poland	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	Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej	Warszawa
Poland	Private Practice	Warszawa
Poland	Private practice	Warszawa
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, I Katedra i Klinika Ginekologii i Poloznictwa	Wroclaw
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	Private Practice	Madrid
Spain	CHIP (Complejo Hospitalario Integral Privado)	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
PregLem SA

Countries where clinical trial is conducted

Austria,  Belgium,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received		From baseline to end of each PGL4001 treatment (3months treatment)	No