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

NCT ID: NCT02068560

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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dDAVP infusion

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

Group Type EXPERIMENTAL

dDAVP infusion

Intervention Type DRUG

Interventions

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dDAVP infusion

Intervention Type DRUG

Other Intervention Names

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desmopressin minirin

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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GenderDifferences

Identifier Type: -

Identifier Source: org_study_id