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

Primary Purpose

Uterine Fibroids

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

PGL4001, placebo, drug free period

PGL4001, progestin, drug free period

About this trial

This is an interventional treatment trial for Uterine Fibroids

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Medical University Vienna, department of obstetrics and gynecology
Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique
CHR de la Citadelle Gynécologie-Obstétrique
Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique
Prywatna Klinika Polozniczo-Ginekologiczna
INVICTA Sp. Z o.o.
Private practice
Private practice
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii
Private Practice
Private practice
Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa
Hospital Universitario Hebron, gynecology department
Clinica Ginecologica CEOGA, departamento de Ginecologia
Private Practice
HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre Departamento de Ginecología
CHIP (Complejo Hospitalario Integral Privado)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01252069

First Posted

November 30, 2010

Last Updated

January 12, 2016

Sponsor

PregLem SA

1. Study Identification

Unique Protocol Identification Number

NCT01252069

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PregLem SA

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Fibroids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

132 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

PGL4001, placebo, drug free period

Other Intervention Name(s)

Ulipristal acetate

Intervention Description

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

Intervention Name(s)

PGL4001, progestin, drug free period

Other Intervention Name(s)

Ulipristal acetate

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

48 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Medical University Vienna, department of obstetrics and gynecology

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

CHR de la Citadelle Gynécologie-Obstétrique

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Prywatna Klinika Polozniczo-Ginekologiczna

City

Bialystok

ZIP/Postal Code

15-224

Country

Poland

Facility Name

INVICTA Sp. Z o.o.

City

Gdańsk

ZIP/Postal Code

80-895

Country

Poland

Facility Name

Private practice

City

Katowice

ZIP/Postal Code

40-724

Country

Poland

Facility Name

Private practice

City

Lodz

ZIP/Postal Code

90-602

Country

Poland

Facility Name

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

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Private Practice

City

Warszawa

ZIP/Postal Code

00-815

Country

Poland

Facility Name

Private practice

City

Warszawa

ZIP/Postal Code

02-066

Country

Poland

Facility Name

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

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

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

City

Wroclaw

ZIP/Postal Code

50-369

Country

Poland

Facility Name

Hospital Universitario Hebron, gynecology department

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Clinica Ginecologica CEOGA, departamento de Ginecologia

City

Lugo

ZIP/Postal Code

27002

Country

Spain

Facility Name

Private Practice

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

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

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

CHIP (Complejo Hospitalario Integral Privado)

City

Malaga

ZIP/Postal Code

29010

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

24630081

Citation

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.

Results Reference

derived

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

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