PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLext2)

PregLem

Status and phase

Completed

Phase 3

Conditions

Uterine Fibroids

Treatments

Drug: Ulipristal Acetate - open label

Study type

Interventional

Funder types

Industry

Identifiers

NCT01642472

PGL11-024

Details and patient eligibility

About

This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl extension 2 (PGL11-024).

This proposed study consists of 4 further consecutive courses of 3 months (84 days) open label ulipristal acetate 10mg once daily treatment each separated by a drug free period.

Enrollment

64 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.