PregLem starts Phase III trials of PGL4001 in Uterine Myoma
PregLem SA announced the start of an international Phase III clinical trial program for PGL4001 (ulipristal) in symptomatic uterine myoma, a common benign solid tumor of the genital tract in women of reproductive age. PGL4001, an orally active, selective progesterone receptor modulator, was shown in a previous Phase II study to be well tolerated and effective both in immediately stopping uterine bleeding, a major symptom associated with the condition, and in reducing myoma volume. Results of the Phase III trials are expected in 2010.
The program is composed of two separate Phase III clinical trials involving a total of 540 patients and being carried out in parallel in a total of 14 countries. The trials are being coordinated by Professor Jacques Donnez of the Université Catholique de Louvain in Brussels.
The first trial (PEARL I) is a randomized, parallel group, double-blind, placebo-controlled, multi-center study on a total of 240 patients. This trial will assess the efficacy and safety of PGL4001 versus placebo over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma. PGL4001 at dosages of 5 and 10 mg will be compared with placebo, with concomitant iron administration in all groups. Parameters to be evaluated include reduction in uterine bleeding, correction of anemia, change in both myoma and uterine volume, and improvement in pain and other symptoms.
The second trial (PEARL II) is a randomized, parallel group, double-blind, double-dummy, active comparator-controlled, multi-center study on a total of 300 patients. This trial will assess the efficacy and safety of PGL4001 versus the only currently approved medication, a GnRH (gonadotropin-releasing hormone) agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma. PGL4001 at dosages of 5 and 10 mg will be compared with leuprorelin 3.75 mg. Parameters to be evaluated will be similar to those in the first trial.
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