Conditions: Uterine Myomas
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 241
Healthy volunteers: no

Brief summary:
This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

Detailed description:

Arms:
arm 1: PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ arm 2: PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ arm 3: PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+

Interventions: intervention 1: PGL4001 (ulipristal) and iron intervention 2: PGL4001 matching placebo and iron intervention 3: PGL4001 (ulipristal) and iron
Intervention descriptions: intervention 1: tablets intervention 2: tablets intervention 3: Tablets

Protocol document: