Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-10 @ 7:27 PM
Study NCT ID:
NCT02068560
Status:
COMPLETED
Last Update Posted:
2014-12-11
First Post:
2014-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053158', 'term': 'Nocturia'}, {'id': 'D053206', 'term': 'Nocturnal Enuresis'}], 'ancestors': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004775', 'term': 'Enuresis'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], 'ancestors': [{'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-10', 'studyFirstSubmitDate': '2014-02-19', 'studyFirstSubmitQcDate': '2014-02-19', 'lastUpdatePostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine osmolality', 'timeFrame': 'Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day'}, {'measure': 'Urine Volume', 'timeFrame': 'Urine Volume is measured every half hour throughout the 9 hours study period'}, {'measure': 'Plasma dDAVP', 'timeFrame': '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'}], 'secondaryOutcomes': [{'measure': 'Plasma sodium', 'timeFrame': 'Plasma sodium is measured every 90 minutes throughout the first 8 hours and every half hour in the last hour of the study periode'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gender Difference in V2 Receptor Function in Response to dDAVP Infusion', 'Nocturia', 'Nocturnal Enuresis']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Normal clinical examination\n* Normal residual urine measurements\n* Normal urine dip stick\n* Informed consent by participant or legal guardian\n\nExclusion Criteria:\n\n* Smoking, alcohol or drug abuse\n* Conditions of importance to the results (endocrinological, renal or cardial)\n* Current or previous history of incontinence, bedwetting or nocturia\n* Drug use of importance (diuretics, hormone replacement therapy, birth control pills, desmopressin)\n* Pregnancy\n* Allergy towards dDAVP/desmopressin'}, 'identificationModule': {'nctId': 'NCT02068560', 'briefTitle': 'The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion', 'orgStudyIdInfo': {'id': 'GenderDifferences'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dDAVP infusion', 'description': 'During the 9 hour study period, the subjects will receive three doses of dDAVP infusion (0.0003micrg/kg, 0.0005micrg/kg, 0.004micrg/kg).', 'interventionNames': ['Drug: dDAVP infusion']}], 'interventions': [{'name': 'dDAVP infusion', 'type': 'DRUG', 'otherNames': ['desmopressin', 'minirin'], 'armGroupLabels': ['dDAVP infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}