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

Nocturia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068560
• Other study ID #: GenderDifferences
• 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

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

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