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Completed

NCT Number: NCT02068560

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

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.

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Key information

Conditions

Gender Difference in V2 Receptor Function in Response to dDAVP Infusion Behavior Behavioral Symptoms Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Nocturia Nocturnal Enuresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

8 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dDAVP infusion

Drug

Other names: desmopressin, minirin

Primary outcomes

  1. Urine osmolality

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

  2. Urine Volume

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

  3. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Ferring Pharmaceuticals

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 21, 2014
Registry last updated
Dec 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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