Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ferring Pharmaceuticals
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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
