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

December 10, 2014 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urine osmolality
Time Frame: Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day
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
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
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

Outcome Measure
Time Frame
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
Plasma sodium is measured every 90 minutes throughout the first 8 hours and every half hour in the last hour of the study periode

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 21, 2014

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GenderDifferences

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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