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

NCT03519750 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-04-30

No results posted yet for this study

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.

Conditions

  • Melatonin
  • Pharmacokinetics
  • Safety

Interventions

DRUG

Melatonin 25 mg

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

Sponsors & Collaborators

  • Copenhagen University Hospital, Denmark

    collaborator OTHER

  • RepoCeuticals ApS

    collaborator UNKNOWN

  • Herlev Hospital

    collaborator OTHER

  • Dennis Bregner Zetner

    lead OTHER

Principal Investigators

  • Dennis B Zetner, MD · Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, Denmark

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-02-21
Completion
2019-02-21

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03519750 on ClinicalTrials.gov