Intervention: Desmopressin
Trial phase: Phase 3
ATC code: H01BA02
SMILES: N=C(N)NCCC[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CSSCCC(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 135
Group description: Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
Eligibility criteria:
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:

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)
Interstitial cystitis
Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours)
Central or nephrogenic diabetes insipidus
Syndrome of inappropriate anti-diuretic hormone secretion
Current or a history of urologic malignancies e.g. bladder cancer
Genitourinary tract pathology e.g., infection or stone in the bladder and urethra causing symptoms
Neurogenic detrusor activity (detrusor overactivity).
Suspicion or evidence of cardiac failure
Uncontrolled hypertension
Uncontrolled diabetes mellitus
Hyponatraemia: Serum sodium level must be within normal limits
Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min
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
History of obstructive sleep apnea
Previous desmopressin treatment for nocturia
Treatment with another investigational product within 3 months prior to screening
Concomitant treatment with any prohibited medication e.g., loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug
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
Known alcohol or substance abuse
Work or lifestyle that may interfere with regular nighttime sleep 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