PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
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.