Uterine Fibroids Clinical Trial
Official title:
A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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