BIOAVAILABILITY OF A NEW ORAL FORMULATION OF MEDROXYPROGESTERONE ACETATE COMPARED WITH THE STANDARD FORMULATION - A SINGLE-DOSE RANDOMIZED STUDY

Twenty-six female patients with breast cancer participated in an open, randomized, cross-over study comparing single dose bloavailability of a recently developed oral medroxyprogesterone acetate (MPA) formulati on (200 mg sachet where MPA is loaded in a polyvinylpyrrolidone cross- linked polymer, MPA/PVP) with the standard formulation (500 mg tablet) . Blood tests were performed under standardized conditions for 120 h i n all patients and MPA plasma concentrations determined by means of HP LC. Dose-normalized AUC(0-t(z)), AUC (0-infinity) and C(max) were all significantly higher for the MPA/PVP formulation than for the standard formulation. The relative bioavailability of the MPA/PVP formulation was on average three times superior to that of the standard formulatio n. This new MPA formulation might have important clinical implications for the treatment of hormone-sensitive cancer.