Conditions: Uterine Myomas
Keywords: Uterine Myomas
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 301
Healthy volunteers: no

Brief summary:
This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, 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: Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection) arm 2: Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection) arm 3: PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)

Interventions: intervention 1: PGL4001 intervention 2: leuprorelin
Intervention descriptions: intervention 1: tablets intervention 2: solution for injection

Protocol document: