PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Inclusion Criteria: * Subject completed visit F - Follow-up of Pearl III extension study (PGL09-027) - without significant deviations. * Females of childbearing potential are advised to practice a non-hormonal method of contraception. Exclusion Criteria: * Subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in Pearl III extension (PGL09-027) or afterwards that would interfere with the study assessments. * Subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol. * Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study. * Subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject's safety or interfere with study evaluations.