Gender Difference in V2 Receptor Function in Response to dDAVP InfusionNCT02068560
The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion
A study testing dDAVP infusion in people with Gender Difference in V2 Receptor Function in Response to dDAVP Infusion and Nocturia, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 8 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender Difference in V2 Receptor Function in Response to dDAVP Infusion, Nocturia, Nocturnal Enuresis
- What is being tested?
- dDAVP infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- May 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy
- Normal clinical examination
- Normal residual urine measurements
- Normal urine dip stick
- Informed consent by participant or legal guardian
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Gender Difference in V2 Receptor Function in Response to dDAVP Infusion, Nocturia, Nocturnal Enuresis
- Being tested
- dDAVP infusion
- Medical subject headings
- Nocturia, Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dDAVP infusionDrug
Also called desmopressin, minirin
| Study group | Role | What they receive |
|---|---|---|
| dDAVP infusion | Experimental | During the 9 hour study period, the subjects will receive three doses of dDAVP infusion (0.0003micrg/kg, 0.0005micrg/kg, 0.004micrg/kg). Receives: Drug: dDAVP infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine osmolality
Measured: Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day
Urine Volume
Measured: Urine Volume is measured every half hour throughout the 9 hours study period
Plasma dDAVP
Measured: 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
Measured: Plasma sodium is measured every 90 minutes throughout the first 8 hours and every half hour in the last hour of the study periode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender Difference in V2 Receptor Function in Response to dDAVP InfusionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068560
- Sponsor's protocol ID
- GenderDifferences
- Status last verified
- Feb 2014
- First submitted
- 19 Feb 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion
- ClinicalTrials.gov ID
- NCT02068560
- Acronym / sponsor ID
- GenderDifferences
- Conditions
- Gender Difference in V2 Receptor Function in Response to dDAVP Infusion, Nocturia, Nocturnal Enuresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dDAVP infusion | Experimental | Drug: dDAVP infusionDuring the 9 hour study period, the subjects will receive three doses of dDAVP infusion (0.0003micrg/kg, 0.0005micrg/kg, 0.004micrg/kg). |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy
- Normal clinical examination
- Normal residual urine measurements
- Normal urine dip stick
- Informed consent by participant or legal guardian
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dDAVP infusionAlso: desmopressin, minirin | Drug | dDAVP infusion |
Primary outcome
Urine osmolality
Time frame: Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day
Urine Volume
Time frame: Urine Volume is measured every half hour throughout the 9 hours study period
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dDAVP infusion in people with Gender Difference in V2 Receptor Function in Response to dDAVP Infusion and Nocturia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine osmolality (time frame: Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.