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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03519750
Other study ID # 2017-000997-13
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 1, 2018
Est. completion date February 21, 2019

Study information

Verified date April 2019
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 21, 2019
Est. primary completion date February 21, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion criteria:

- Healthy female

- 20-40 years old

- BMI 18-30

Exclusion criteria:

- Inability to understand Danish, written or spoken.

- Current use of melatonin or other hypnotics/sedatives

- Current pregnancy (a positive urine-HCG; the subjects will be tested prior to each study session)

- Breast feeding

- Current alcohol or drug abuse (defined as over 5 units of alcohol per day, or any usage of illegal drugs)

- Mental illness (defined as being in medical treatment)

- Serious comorbidity (American Society of Anesthesiologists (ASA) physical status 3-4)

- Participation in other clinical trials less than 1 month prior to current study

- Night-shift work within the last 14 days prior to study

- Planned night-shift work within the study period

- Known and diagnosed sleep-disorder (defined as being in current medical treatment)

- Plasma hemoglobin <7.8 mmol/L (measured when screening participants)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Melatonin 25 mg
24-48 hour monitoring of plasma melatonin as well as adverse events.

Locations

Country Name City State
Denmark Herlev Hospital Herlev

Sponsors (4)

Lead Sponsor Collaborator
Dennis Bregner Zetner Copenhagen University Hospital, Denmark, Herlev Hospital, RepoCeuticals ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary Karolinska Sleepiness Scale Scale which evaluates tiredness of participants 0 minutes, once hourly for 8 hours, and again at 24 hours
Secondary 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. 0 minutes, once hourly for 8 hours, and again at 24 hours
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