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TAK-385 Summary

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MacLean et al. (2015) addresses the efficacy for the GnRH antagonist TAK-385, based on a three-part, placebo-controlled study. The study examined (n=176) healthy UK males, with the age range of 19 to 75 years old. The first part included the dose of TAK-385 20-mg tablets or a placebo. The 14-day part two included the daily dose of TAK-385 20-mg tablets or a placebo. The 28-day part three included the daily dose of TAK-385 20- or 80-mg or a placebo. In part 1, luteinizing hormone (LH) levels decreased, as well as serum testosterone levels. In part 2, with doses of at least 40 mg/d, LH and follicle-stimulating hormone (FSH) levels decreased and after multiple doses the mean testosterone levels dropped below the threshold for medical castration. In part 3, serum testosterone levels dropped most rapidly and medical castration was achieved. Doses greater than 80 mg/d of TAK-385 reduced the serum testosterone levels below castration levels. Conclusively, GnRH is a valid option for testosterone suppression and ultimately serves as an effective prostate cancer hormone therapy treatment. …show more content…

(2012) highlighted a key difference in long term use of monthly GhRH antagonist degarelix (240/80 mg) over LHRH agonist goserelin (3.6mg) in a study that included (n=175) patients completing the trial over 12 weeks. Goserelin treated patients were given bicalutamide (50 mg) in combination on a daily basis for the first 28 days to control hormone flares and related side effects. This study was a randomized parallel-arm, open label, multicenter trial that found the short term efficacy to be the same in both when controlling the total prostate volume (TPV) and relief of lower urinary tract symptoms (LUTS), but more favorable over long term treatment in degarelix patients for LUTS relief. These findings potentially extrapolated the different overall effects on the GnRH receptors in the bladder and prostate with efficacy favoring degarelix in long term

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