PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Phase 3

Completed

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

• Registration Number: NCT01156857
• Lead Sponsor: PregLem SA

Brief Summary

This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.

Detailed Description

PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-02
• Study First Posted: 2010-07-05
• Primary Completion: 2011-11
• Study Completion: 2012-02
• Status Verified: 2013-06
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 209

Inclusion Criteria

• Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
• Subject with a Body Mass Index ≥18 and ≤40.
• Subject with myomatous uterus size < 16 weeks.
• Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.
• Subject complained of strong uterine bleeding.
• Subject is eligible for hysterectomy or myomectomy.
• Females of childbearing potential have to practice a non-hormonal method of contraception.

Exclusion Criteria

• Subject has a history of or current uterus, cervix, ovarian or breast cancer.
• Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.
• Subject has a known severe coagulation disorder.
• Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
• Subject has abnormal hepatic function at study entry.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	PGL4001, placebo	Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
B	PGL4001, progestin	Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets).

Primary Outcome Measures

Name	Time	Method
Efficacy endpoints	From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.	Investigate efficacy of PGL4001 on uterine bleeding (% of subjects in amenorrhea at end of PGL4001 treatment), myoma size (transvaginal ultrasound), pain (short Mc Gill questionnaire) and quality of life (specific UFS-QoL questionnaire and general EQ-5D questionnaire).
Number and proportion of subjects experiencing open label treatment-emergent adverse events	From baseline to end of PGL4001 treatment (3months treatment)

Trial Locations

Locations (20)

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

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

Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium

CHR de la citadelle; 🇧🇪 Liège, Belgium

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

Prywatna Klinika Polozniczo-Ginekologiczna; 🇵🇱 Bialystok, Poland

INVICTA Sp. Z o.o.; 🇵🇱 Gdańsk, Poland

Private Practice; 🇵🇱 Warszawa, 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

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