Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT03519750
Status:
COMPLETED
Last Update Posted:
2019-04-30
First Post:
2018-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Melatonin in Healthy Female Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-05', 'size': 831673, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-04-16T07:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each volunteer will have melatonin administered through all five routes of administration, and will have a wash-out of a minimum of 7 days between each administration.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-29', 'studyFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2018-05-08', 'lastUpdatePostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration of melatonin', 'timeFrame': 'Baseline, 0 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 24 hours', 'description': 'Plasma concentration of melatonin'}, {'measure': 'Plasma concentration of melatonin', 'timeFrame': 'Baseline, 0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 48 hours', 'description': 'Plasma concentration of melatonin'}], 'secondaryOutcomes': [{'measure': 'Karolinska Sleepiness Scale', 'timeFrame': '0 minutes, once hourly for 8 hours, and again at 24 hours', 'description': 'Scale which evaluates tiredness of participants'}, {'measure': 'Simple Reaction Time Test', 'timeFrame': '0 minutes, once hourly for 8 hours, and again at 24 hours', 'description': "A simple reaction time test which measures the participants' reaction time; they are looking at a red lamp, and need to react when it changes to green."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melatonin', 'Safety', 'Pharmacokinetics'], 'conditions': ['Melatonin', 'Pharmacokinetics', 'Safety']}, 'descriptionModule': {'briefSummary': 'We will investigate the safety and pharmacokinetics of melatonin, when administered rectally, intravesically, vaginally and transdermally. We will recruit 10 healthy female volunteers. The volunteers will have melatonin administered over 5 days; intravenously, rectally, intravesically, vaginally and transdermally. The participants will be followed for 24-48 hours with blood samples and questions about adverse events. There will be a wash-out between each session of a minimum of 7 days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'They need to be female, in order to receive vaginal administration of melatonin', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy female\n* 20-40 years old\n* BMI 18-30\n\nExclusion criteria:\n\n* Inability to understand Danish, written or spoken.\n* Current use of melatonin or other hypnotics/sedatives\n* Current pregnancy (a positive urine-HCG; the subjects will be tested prior to each study session)\n* Breast feeding\n* Current alcohol or drug abuse (defined as over 5 units of alcohol per day, or any usage of illegal drugs)\n* Mental illness (defined as being in medical treatment)\n* Serious comorbidity (American Society of Anesthesiologists (ASA) physical status 3-4)\n* Participation in other clinical trials less than 1 month prior to current study\n* Night-shift work within the last 14 days prior to study\n* Planned night-shift work within the study period\n* Known and diagnosed sleep-disorder (defined as being in current medical treatment)\n* Plasma hemoglobin \\<7.8 mmol/L (measured when screening participants)'}, 'identificationModule': {'nctId': 'NCT03519750', 'briefTitle': 'Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Melatonin in Healthy Female Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Administration of Exogenous Melatonin in Healthy Female Volunteers: a Crossover Study', 'orgStudyIdInfo': {'id': '2017-000997-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous melatonin', 'description': 'Intravenous administration, making it possible to calculate bioavailability for other routes of administration', 'interventionNames': ['Drug: Melatonin 25 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Rectal melatonin', 'description': 'Rectal administration of melatonin', 'interventionNames': ['Drug: Melatonin 25 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Intravesical melatonin', 'description': 'Intravesical administration of melatonin', 'interventionNames': ['Drug: Melatonin 25 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Vaginal melatonin', 'description': 'Vaginal administration of melatonin', 'interventionNames': ['Drug: Melatonin 25 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Transdermal melatonin', 'description': 'Transdermal administration of melatonin', 'interventionNames': ['Drug: Melatonin 25 mg']}], 'interventions': [{'name': 'Melatonin 25 mg', 'type': 'DRUG', 'description': '24-48 hour monitoring of plasma melatonin as well as adverse events.', 'armGroupLabels': ['Intravenous melatonin', 'Intravesical melatonin', 'Rectal melatonin', 'Transdermal melatonin', 'Vaginal melatonin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Dennis B Zetner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dennis Bregner Zetner', 'class': 'OTHER'}, 'collaborators': [{'name': 'Copenhagen University Hospital, Denmark', 'class': 'OTHER'}, {'name': 'RepoCeuticals ApS', 'class': 'UNKNOWN'}, {'name': 'Herlev Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dennis Bregner Zetner', 'investigatorAffiliation': 'Herlev Hospital'}}}}