Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Melatonin in Healthy Female Volunteers

Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Administration of Exogenous Melatonin in Healthy Female Volunteers: a Crossover Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03519750

Enrollment

Registered

2018-05-09

Start date

2018-11-01

Completion date

2019-02-21

Last updated

2019-04-30

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

Conditions

Melatonin, Pharmacokinetics, Safety

Keywords

Melatonin, Safety, Pharmacokinetics

Brief 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.

Interventions

DRUGMelatonin 25 mg

24-48 hour monitoring of plasma melatonin as well as adverse events.

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

Measure	Time frame	Description
Karolinska Sleepiness Scale	0 minutes, once hourly for 8 hours, and again at 24 hours	Scale which evaluates tiredness of participants
Simple Reaction Time Test	0 minutes, once hourly for 8 hours, and again at 24 hours	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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026