AEterna Zentaris: Article on Phase 2 Trial with Cetrorelix in BPH to be Published in European Urolo...(ily dosing suggested the use of the lute...)

Trial Design

After a run-in period with four weekly injections of placebo, 140 patients with an international prostate symptoms score (I-PSS) >= 13 and a peak urinary flow rate (PFR) 5-13 ml/s were randomly allocated to four treatment groups. Patients received either cetrorelix at dosages of 5 mg/wk x 4, 10 mg/wk x 2 or 10 mg/wk x 4 or placebo.

Main and secondary endpoints included I-PSS, PFR and mean uroflow, residual urinary volume, prostate volume, plasma testosterone, quality of life, and sexual function which were evaluated over a total of 20 weeks after randomization.

Results

In all cetrorelix groups, a rapid improvement in mean I-PSS was obtained, with a peak effect of -5.4 to -5.9 (placebo: -2.8). After all dosages of cetrorelix given, changes from baseline and differences to placebo were statistically significant up to week 20. Similarly, secondary parameters showed a significant, rapid, and persistent improvement for all cetrorelix dosages. All dosage regimens were well tolerated. The study evaluated a single treatment course only; further studies with repeated treatment courses will be required to establish a dose regimen for long-term disease management.

Conclusions

In summary, the trial showed a rapid onset in improvement of I-PSS, urinary symptoms and quality of life, accompanied by a slight reduction in prostate size with a short course therapy with cetrorelix. The improvement lasted well beyond the dosing period. This should, therefore, allow for the development of intermittent dosage regimens of cetrorelix with two or three treatment courses per year, thus relieving concerns about treatment compliance with drugs requiring daily dosing.

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