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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02068560
Other study ID # GenderDifferences
Secondary ID
Status Completed
Phase N/A
First received February 19, 2014
Last updated December 10, 2014
Start date May 2012
Est. completion date December 2014

Study information

Verified date February 2014
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years to 80 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
dDAVP infusion


Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Ferring Pharmaceuticals

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urine osmolality Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day No
Primary Urine Volume Urine Volume is measured every half hour throughout the 9 hours study period No
Primary Plasma dDAVP 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 No
Secondary Plasma sodium Plasma sodium is measured every 90 minutes throughout the first 8 hours and every half hour in the last hour of the study periode Yes
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