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

Inclusion criteria

• Has given written consent prior to any trial-related activity is performed.
• Female 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

• Showing symptoms of any of the following diseases: 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.
• 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 >0.82 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.
• Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial.
• 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.