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| Name | Class |
|---|---|
| Copenhagen University Hospital, Denmark | OTHER |
| RepoCeuticals ApS | UNKNOWN |
| Herlev Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous melatonin | Active Comparator | Intravenous administration, making it possible to calculate bioavailability for other routes of administration |
|
| Rectal melatonin | Experimental | Rectal administration of melatonin |
|
| Intravesical melatonin | Experimental | Intravesical administration of melatonin |
|
| Vaginal melatonin | Experimental | Vaginal administration of melatonin |
|
| Transdermal melatonin | Experimental | Transdermal administration of melatonin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 25 mg | Drug | 24-48 hour monitoring of plasma melatonin as well as adverse events. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of melatonin | Plasma concentration of melatonin | 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 |
| Plasma concentration of melatonin | Plasma concentration of melatonin | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Karolinska Sleepiness Scale | Scale which evaluates tiredness of participants | 0 minutes, once hourly for 8 hours, and again at 24 hours |
| Simple Reaction Time Test | 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. |
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Inclusion criteria:
Exclusion criteria:
They need to be female, in order to receive vaginal administration of melatonin
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| Name | Affiliation | Role |
|---|---|---|
| Dennis B Zetner, MD | Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | 2000 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2018 | Apr 16, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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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.
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| 0 minutes, once hourly for 8 hours, and again at 24 hours |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |