Absorption and excretion of melatonin when applied intravenously, rectally, in the bladder, vaginally and dermally in healthy female volunteers

Phase 1

• Conditions: Pharmacokinetics of melatonin; MedDRA version: 20.0 Level: LLT Classification code 10053349 Term: Pharmacokinetic study System Organ Class: 100000004848; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2017-000997-13-DK
• Lead Sponsor: Center for Perioperative Optimization, Department of Surgery, Herlev Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Healthy female
20-40 years old
BMI 18-30

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified