- Placebo; - Ozarelix 5 mg on Day 1 + 5 mg on Day 15; - Ozarelix 10 mg on Day 1 +10 mg on Day 15; - Ozarelix 15 mg on Day 1 + 15 mg on Day 15; or - Ozarelix 20 mg on Day 1 only.
Patients were followed for 28 weeks. The primary efficacy endpoint was change in IPSS at week 12 compared to baseline. Secondary efficacy endpoints included changes in IPSS, Quality of Life (QoL), patients with >= 30% and >= 40% improvement in IPSS, uroflow values (Qmax), postvoid residual (PVR) urine volume and prostate volume. Safety analysis included changes in sexual function (IIEF-5), treatment of emergent adverse events (AEs), lab values (including testosterone (T), PSA) and vital signs. Mean age was 69.1 (range 52 - 85), IPSS 19.8, Qmax 9.7 mL/sec. and prostate size (cm(3)) 41.6 at baseline.
The effects developed rapidly, with noticeable activity at four weeks from starting treatment, were maximal at 12-16 weeks, and persisted for the 6 month observation period. At week 12, all ozarelix-treated groups showed improvement with the greatest improvement in the 15 mg + 15 mg group. Change from baseline in IPSS was 8.6 (p<0.001); change from baseline in urine flow was 4.7 (p=0.002); T levels declined transiently and returned to baseline in most patients by 4 weeks and all patients by 6 weeks following dosing. Based on IIEF, there was no effect seen on erectile function.
Serious adverse events were reported in 4 patients on ozarelix (myocardial infarction, pneumonitis, hypotension, renal colic), but were not considered treatment related. No systemic allergic reactions were seen and the injections were well tolerated.
Conclusions - Ozarelix was well tolerated; - Statistically sig
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