Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)

Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)

PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)

tablets

Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.

Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.

A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.

Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.

The week 13 PBAC score was calculated using the last 28 days of treatment.

Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples

Difference in percentage of subjects reporting moderate or severe hot flushes:

Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17.

Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.

The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10).