13. Patients with bilateral hydronephrosis or bladder neck outlet obstruction. 14. Known hypersensitivity to TAK-385, TAK-385 excipients, or GnRH antagonists. 15. Patients with a past history of gastrointestinal tract treatments (including gastrectomy) or gastrointestinal disease that could affect the drug absorption or tolerability (malabsorption, esophageal reflux, peptic ulcer, erosive esophagitis).