Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT01184859
Eligibility Criteria:
Inclusion Criteria:
* Given written informed consent prior to any trial-related activity is performed
* Aged 55-75 years
* Mean number of nocturnal voids of at least two per night
* Reached post-menopause (applicable to females only)
Exclusion Criteria:
* Evidence of bladder outlet obstruction (BOO); or a urine flow of less than 5 mL/s (applicable to males only)
* A surgical treatment for BOO or prostatic hyperplasia within the past 6 months (applicable to males only)
* Showing symptoms of any of the following diseases and having a mean number of nocturnal voids exceeding four per night: Benign prostatic hyperplasia, overactive bladder, interstitial cystitis, severe stress urinary incontinence
* Psychosomatic or habitual polydipsia
* Urinary retention; or a post void residual volume in excess of 150 mL
* A history or complication of urologic malignancy (e.g. bladder cancer or prostate cancer)
* Complication of genito-urinary pathology (e.g. infection, stone, or neoplasia)
* Complication of neurogenic detrusor activity
* Complication or suspicion of heart failure
* Uncontrolled hypertension
* Uncontrolled diabetes mellitus
* Complication of hepatobiliary disease
* Abnormal serum creatinine level
* Complication of hyponatraemia, or serum sodium level \<135 mEq/L
* Central or nephrogenic diabetes insipidus (CDI or NDI)
* Syndrome of inappropriate antidiuretic hormone (SIADH)
* Obstructive sleep apnea
* Alcohol dependency or drug abuse
* A job or lifestyle that may interfere with regular night-time sleep
* Previous desmopressin treatment
* Treatment with another investigational product within the past 3 months
* A need for treatment with a prohibited concomitant drug for a complication or other problem
* A mental condition, the lack of decision-making ability, dementia or a speech handicap
* Any other reason that the Investigator believes inappropriate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT01184859
Study Brief:
Protocol Section:
NCT01184859