Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients

A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablet for the Treatment of Nocturia in Adult Females

A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to investigate the safety and efficacy of desmopressin oral melt tablets against placebo during 3 months of treatment in adult females with nocturia.

Inclusion Criteria:

• Written informed consent prior to performance of any trial-related activity
• Female sex 18 years of age or older
• At least 2 voids every night in a consecutive 3-day period during the screening period

Exclusion Criteria:

1. Evidence of severe daytime voiding dysfunction defined as:

   • Urge urinary incontinence (more than 1 episode/day in the 3-day diary period)
   • Urgency (more than 1 episode/day in the 3-day diary period)
   • Frequency (more than 8 daytime voids/day in the 3-day diary period)

2. Interstitial cystitis

3. Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention

4. Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours)

5. Central or nephrogenic diabetes insipidus

6. Syndrome of inappropriate anti-diuretic hormone secretion

7. Current or a history of urologic malignancies e.g. bladder cancer

8. Genitourinary tract pathology e.g., infection or stone in the bladder and urethra causing symptoms

9. Neurogenic detrusor activity (detrusor overactivity).

10. Suspicion or evidence of cardiac failure

11. Uncontrolled hypertension

12. Uncontrolled diabetes mellitus

13. Hyponatraemia: Serum sodium level must be within normal limits

14. Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min

15. Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL

16. History of obstructive sleep apnea

17. Previous desmopressin treatment for nocturia

18. Treatment with another investigational product within 3 months prior to screening

19. Concomitant treatment with any prohibited medication e.g., loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug

20. Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial. Subjects of reproductive age must have documentation of a reliable method of contraception. All pre-and perimenopausal subjects have to perform pregnancy tests. Amenorrhea of more than 12 months' duration based on the reported date of the last menstrual period is sufficient documentation of post-menopausal status and does not require a pregnancy test

21. Known alcohol or substance abuse

22. Work or lifestyle that may interfere with regular nighttime sleep e.g., shift workers

23. 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