Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Female Subjects

Exclusion Criteria

• •Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 2
• •History or evidence of significant obstructive sleep apnoea
• •History or diagnosis of any of the following urological diseases at Visit 1:
• •* Interstitial cystitis or bladder pain disorder
• •* Stress urinary incontinence or mixed incontinence, where stress incontinence is the predominant component based on prior history
• •* Chronic pelvic pain syndrome
• •Surgical treatment, including transurethral resection, for bladder outlet obstruction (BOO) within the past 6 months prior to Visit 1
• •Symptoms of severe over-active bladder (OAB):
• •* Defined as an over-active bladder symptom score (OABSS) ≥12 at Visit 1
• •* Defined as a mean of \>8 voids and a mean of ≥1 urgency episode per 24 hours at the end of the screening period prior to Visit 2
• •Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence at Visit 1
• •Complication of cancer or a history of cancer which has not been in remission for the last 5 years at Visit 1
• •Current or a history of urologic malignancies, any lower urinary tract surgery, previous pelvic irradiation, or neoplasia at Visit 1
• •History of any neurological disease affecting bladder function or muscle strength at Visit 1
• •Urinary retention or a post void residual volume \>150 mL
• •Habitual or psychogenic polydipsia based on medical history at Visit 1 or 24 hour urine output of \>2.8 L based on the voiding diary at Visit 2
• •Central or nephrogenic diabetes insipidus at Visit 1
• •Syndrome of inappropriate antidiuretic hormone secretion at Visit 1
• •Suspicion or evidence of cardiac failure at Visit 1
• •Uncontrolled hypertension at Visit 1
• •Uncontrolled diabetes mellitus at Visit 1
• •Hyponatraemia (serum sodium level \<135 mmol/L) at Visit 1
• •Renal insufficiency at Visit 1
• •Hepatic and/or biliary diseases at Visit 1
• •Known or suspected hypersensitivity to desmopressin ODTs or previous desmopressin treatment for nocturia at Visit 1
• •Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial.
• •Known alcohol or substance abuse at Visit 1
• •Work or lifestyle that may interfere with regular night-time sleep at Visit 1, e.g., shift workers
• •Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the investigator, would impair participation in the trial at Visit 1
• •Use of any prohibited therapy during the trial period