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

Phase 3CompletedNCT01252069

PregLem SA132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

132

Conditions

Uterine Fibroids

Interventions

PGL4001, placebo, drug free periodDRUG

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 periodDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 48 Years

Medical Language ↔ Plain English

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.

Locations (18)

Medical University Vienna, department of obstetrics and gynecology

Vienna, Austria

Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.