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

Primary Purpose

Gender Difference in V2 Receptor Function in Response to dDAVP Infusion, Nocturia, Nocturnal Enuresis

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

dDAVP infusion

About this trial

This is an interventional basic science trial for Gender Difference in V2 Receptor Function in Response to dDAVP Infusion

Eligibility Criteria

8 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dDAVP infusion

Arm Description

During the 9 hour study period, the subjects will receive three doses of dDAVP infusion (0.0003micrg/kg, 0.0005micrg/kg, 0.004micrg/kg).

Outcomes

Primary Outcome Measures

Urine osmolality

Urine Volume

Plasma dDAVP

Secondary Outcome Measures

Plasma sodium

Full Information

NCT ID

NCT02068560

First Posted

February 19, 2014

Last Updated

December 10, 2014

Sponsor

University of Aarhus

Collaborators

Ferring Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02068560

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gender Difference in V2 Receptor Function in Response to dDAVP Infusion, Nocturia, Nocturnal Enuresis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dDAVP infusion

Arm Type

Experimental

Arm Description

During the 9 hour study period, the subjects will receive three doses of dDAVP infusion (0.0003micrg/kg, 0.0005micrg/kg, 0.004micrg/kg).

Intervention Type

Drug

Intervention Name(s)

dDAVP infusion

Other Intervention Name(s)

desmopressin, minirin

Primary Outcome Measure Information:

Title

Urine osmolality

Time Frame

Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day

Title

Urine Volume

Time Frame

Urine Volume is measured every half hour throughout the 9 hours study period

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Aarhus University Hospital

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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