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The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion

This study has been completed.
Ferring Pharmaceuticals
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: February 19, 2014
Last updated: December 10, 2014
Last verified: February 2014

There is substantial evidence that women throughout life have significantly lower plasma levels of the antidiuretic hormone vasopressin (pAVP) compared to men. The importance of this is not yet fully elucidated, but in relation to the observations of lower pAVP levels, no significant difference in renal response parameters was found. This could be interpreted an increased renal sensitivity in females compared to males. The theory of increased renal sensitivity in females is supported by a few pharmacodynamic studies currently available on this topic. However none of the studies was designed with the purpose of investigate the gender difference.

The aim of this study is to investigate possible gender differences in the renal sensitivity to dDAVP and the effect of age on these differences. This will be done by low dose graded infusion of the synthetic AVP analog dDAVP.

Participants are 80 healthy volunteers equally distributed between four age groups, 8-10 years of age, 16-18 years of age, 25-40 years og age and 65+ years of age.

Condition Intervention
Gender Difference in V2 Receptor Function in Response to dDAVP Infusion
Nocturnal Enuresis
Drug: dDAVP infusion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Urine osmolality [ Time Frame: Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day ]
  • Urine Volume [ Time Frame: Urine Volume is measured every half hour throughout the 9 hours study period ]
  • Plasma dDAVP [ Time Frame: Plasma concentrations of the synthetic hormone is measured every 90 minutes for the first 8 hours and every half hour, the last hour of the study period ]

Secondary Outcome Measures:
  • Plasma sodium [ Time Frame: Plasma sodium is measured every 90 minutes throughout the first 8 hours and every half hour in the last hour of the study periode ]

Enrollment: 64
Study Start Date: May 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dDAVP infusion
During the 9 hour study period, the subjects will receive three doses of dDAVP infusion (0.0003micrg/kg, 0.0005micrg/kg, 0.004micrg/kg).
Drug: dDAVP infusion
Other Names:
  • desmopressin
  • minirin


Ages Eligible for Study:   8 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy
  • Normal clinical examination
  • Normal residual urine measurements
  • Normal urine dip stick
  • Informed consent by participant or legal guardian

Exclusion Criteria:

  • Smoking, alcohol or drug abuse
  • Conditions of importance to the results (endocrinological, renal or cardial)
  • Current or previous history of incontinence, bedwetting or nocturia
  • Drug use of importance (diuretics, hormone replacement therapy, birth control pills, desmopressin)
  • Pregnancy
  • Allergy towards dDAVP/desmopressin
  Contacts and Locations
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Please refer to this study by its identifier: NCT02068560

Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Ferring Pharmaceuticals
  More Information

Responsible Party: University of Aarhus Identifier: NCT02068560     History of Changes
Other Study ID Numbers: GenderDifferences
Study First Received: February 19, 2014
Last Updated: December 10, 2014

Additional relevant MeSH terms:
Nocturnal Enuresis
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Deamino Arginine Vasopressin
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs processed this record on May 24, 2017