PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4

Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval.

Time frame: After 18 months

Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses

Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding during the last 56 days of a treatment course. Subjects need to be in controlled bleeding at the end of all 4 treatment courses i.e. for at least 4x56 days.

Time frame: After 18 months

Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids

For the 3 largest myomas at baseline and the 3 largest myomas at the end of treatment course 4 identified by transvaginal ultrasound, length, height and depth were measured and the volume was estimated by applying the equation for the voulme of an ellipsoid (length x height x depht x π/6). Subjects were exposed to 4 3-month intermittent courses.

Time frame: After 18 months

Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)

Quality of Life was assessed using a validated questionnaire measuring uterine fibroid symptom severity (UFSQoL) where lower scores indicate fewer symtoms and where a level of 23 has been reported for healthy subject (scale 0-100). Subjects were exposed to 4 3-month intermittent courses.