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

Phase 1

Completed

• Conditions: Melatonin; Pharmacokinetics; Safety
• Interventions: Drug: Melatonin 25 mg

• Registration Number: NCT03519750
• Lead Sponsor: Dennis Bregner Zetner

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-09
• Study Start: 2018-11-01
• Primary Completion: 2019-02-21
• Study Completion: 2019-02-21
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intravenous melatonin	Melatonin 25 mg	Intravenous administration, making it possible to calculate bioavailability for other routes of administration
Rectal melatonin	Melatonin 25 mg	Rectal administration of melatonin
Intravesical melatonin	Melatonin 25 mg	Intravesical administration of melatonin
Vaginal melatonin	Melatonin 25 mg	Vaginal administration of melatonin
Transdermal melatonin	Melatonin 25 mg	Transdermal administration of melatonin

Primary Outcome Measures

Name	Time	Method
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	Plasma concentration of melatonin

Secondary Outcome Measures

Name	Time	Method
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.
Karolinska Sleepiness Scale	0 minutes, once hourly for 8 hours, and again at 24 hours	Scale which evaluates tiredness of participants

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark