Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Men

Inclusion Criteria: * Has given written consent prior to any trial-related activity is performed * Male sex, aged 20 years or older * At least 2 nocturnal voids every night in a consecutive 3-day period as documented in the diary during the screening period * Has given agreement about contraception during the trial Exclusion Criteria: * Suspicion of bladder outlet obstruction or a urine flow of less than 5 mL/s as confirmed by uroflowmetry after suspicion of bladder outlet obstruction * A surgical treatment for bladder outlet obstruction or prostatic hyperplasia within the past 6 months * Showing symptoms of any of the following diseases: Benign prostatic obstruction; Interstitial cystitis; Overactive bladder, defined as \>6 daytime voids, ≥1 urgency episode, and ≥1 urge urinary incontinence episode per 24 hours as documented in the 3-day diary period; Severe stress urinary incontinence * Chronic prostatitis/chronic pelvic pain syndrome * Psychogenic or habitual polydipsia * Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention * Cancer * A history of urologic malignancies or a history of cancer which has not been in remission for the last 5 years * Genito-urinary tract pathology * Neurogenic detrusor activity * Suspicion or evidence of heart failure * Uncontrolled hypertension * Uncontrolled diabetes mellitus * Hepatobiliary diseases: Aspartate aminotransferase \>80 U/L or alanine aminotransferase \>90 U/L; Total bilirubin \>1.5 mg/dL * Renal insufficiency: Serum creatinine level \>1.09 mg/dL; Estimated glomerular filtration rate \<50 mL/min * Hyponatraemia: Serum sodium level \<135 mEq/L * Central or nephrogenic diabetes insipidus * Syndrome of inappropriate antidiuretic hormone * Obstructive sleep apnea * Previous desmopressin treatment * Treatment with another investigational product within the past 3 months * Concomitant treatment with any prohibited medication * Alcohol or substance abuse * A job or lifestyle that may interfere with regular night-time sleep * A mental condition, lack of decision-making ability, dementia, a speech handicap, or any other reason which, in the judgement of the investigator (sub-investigator), would impair the participation in the trial