Trial-A compared 3 regimens of subcutaneous cetrorelix acetate with placebo (35 patients/group): 5mg x 4, 7 days apart; 10mg x 4, 7 days apart; and 10mg x 2, 14 days apart.
Trial-B compared 4 regimens of intramuscular cetrorelix pamoate with placebo (30 patients/group, 14 days between doses): 30mg x 2; 30mg x 3; 60mg and 30mg; 60mg x 2. Patients were followed up for 20 and 28 weeks after the first dose in Trial-A and B, respectively. International Prostate Symptom Score (I-PSS) primary endpoint was assessed in 4-weekly intervals; other endpoints included uroflow, prostate size, and testosterone levels.
In both trials, 4 weeks after first dose, all regimens showed a statistically significant reduction in I-PSS from baseline; at week 12, the difference from placebo was statistically significant for all dosage regimens except the 30mg x 2 in Trial-B (Trial-A: p<0.05; Trial-B: p <0.001). Generally, the improvement in I-PSS, which tended to be better in the higher dosage groups of Trial-B (reduction of 5-7 points, i.e. 30%-40%), was maintained throughout the follow-up period and was paralleled by an improvement in uroflow. A slight, dose-dependent reduction in prostate size was noticed in both trials. All dosage regimens tested were well tolerated, and none were associated with sexual side effects.
In both studies, a prolonged duration of effect extending far beyond the end of the short-term treatment course was observed. For the long-term management of BPH patients, the results from both studies support a 6-month interval between subsequent treatment courses.
Cetrorelix is part of AEterna Zentaris' LHRH antagonist therapeutic
approach that has de
|SOURCE AETERNA ZENTARIS INC.|
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