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

Pharmacokinetics of intravenous, rectal, intravesical, vaginal, and transdermal administration of exogenous melatonin in healthy female volunteers: a crossover study

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000997-13-DK

Enrollment

Registered

2017-11-15

Start date

2018-03-02

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics of melatonin MedDRA version: 20.0 Level: LLT Classification code 10053349 Term: Pharmacokinetic study System Organ Class: 100000004848

Interventions

Product Name: Melatonin Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion INN or Proposed INN: Melatonin CAS Number

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to determine the pharmacokinetic properties, and possible adverse reactions of melatonin when administered rectally, intravesically, vaginally, transdermally and intravenously, in healthy female volunteers. ;Secondary Objective: The secondary objectives is to assess the safety of melatonin when administered intravenously, intravesically, transdermally, vaginally and rectally, in healthy female volunteers.;Primary end point(s): Plasmaconcentration of melatonin; Timepoint(s) of evaluation of this end point: Intravenous, rectal, intravesical and vaginal administration: Baseline and at T = 0 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours and 24 hours Transdermal administration: Baseline and at T = 0 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours and 48 hours T = time after administration of melatonin	—

Measure

Time frame

Main Objective: The aim of the study is to determine the pharmacokinetic properties, and possible adverse reactions of melatonin when administered rectally, intravesically, vaginally, transdermally and intravenously, in healthy female volunteers. ;Secondary Objective: The secondary objectives is to assess the safety of melatonin when administered intravenously, intravesically, transdermally, vaginally and rectally, in healthy female volunteers.;Primary end point(s): Plasmaconcentration of melatonin; Timepoint(s) of evaluation of this end point: Intravenous, rectal, intravesical and vaginal administration: Baseline and at T = 0 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours and 24 hours Transdermal administration: Baseline and at T = 0 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours and 48 hours T = time after administration of melatonin

—

Secondary

Measure	Time frame
Secondary end point(s): Karolinska Sleepiness Scale Simple Reaction Time test ; Timepoint(s) of evaluation of this end point: Intravenous, rectal, intravesical and vaginal administration: Baseline and T = 1, 2, 3, 4, 6, 8 and 24 hours Transdermal administration: Baseline and T = 1, 2, 3, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 24 and 48 hours T = time after administration of melatonin	—

Countries

Denmark

Contacts

Public ContactDennis Bregner Zetner

Center for Perioperative Optimization, Gastroenheden D, Herlev Hospital

dennis.zetner@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026