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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Aarhus
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02068560
First received: February 19, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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
Nocturia
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 ] [ Designated as safety issue: No ]
  • Urine Volume [ Time Frame: Urine Volume is measured every half hour throughout the 9 hours study period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 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

  Eligibility

Ages Eligible for Study:   8 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068560

Contacts
Contact: Marie K Schroder, MD + 45 78 45 15 23 mkschroder@ki.au.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Marie K Schroder, MD    + 78 45 15 23    mkschroder@ki.au.dk   
Sponsors and Collaborators
University of Aarhus
Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02068560     History of Changes
Other Study ID Numbers: GenderDifferences
Study First Received: February 19, 2014
Last Updated: February 19, 2014
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Nocturnal Enuresis
Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014