A Phase III, Multicentre, Extension Study Investigating the Efficacy and Safety of Repeated Intermittent 3-month Courses of Open-label Administration of Ulipristal Acetate, in Subjects With Symptomatic Uterine Myomas and Heavy Uterine Bleeding
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
Average score of the first 3 questions.
After 18 months.
Belgium: Federal Agency for Medicinal Products and Health Products