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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02068560
Enrollment
64
Registered
2014-02-21
Start date
2012-05-31
Completion date
2014-12-31
Last updated
2014-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGdDAVP infusion

Sponsors

Ferring Pharmaceuticals
CollaboratorINDUSTRY
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Urine osmolalitySamples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day
Urine VolumeUrine Volume is measured every half hour throughout the 9 hours study period
Plasma dDAVPPlasma 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

MeasureTime frame
Plasma sodiumPlasma sodium is measured every 90 minutes throughout the first 8 hours and every half hour in the last hour of the study periode

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026