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OpenTrials
Completed

NCT Number: NCT03519750

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

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.

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Key information

Conditions

Melatonin Pharmacokinetics Safety

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Herlev Hospital

Herlev, 2000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Melatonin 25 mg

Drug

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

Primary outcomes

  1. Plasma concentration of melatonin

    Time frame: 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

  2. Plasma concentration of melatonin

    Time frame: 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 outcomes

  1. Karolinska Sleepiness Scale

    Time frame: 0 minutes, once hourly for 8 hours, and again at 24 hours

    Scale which evaluates tiredness of participants

  2. Simple Reaction Time Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dennis Bregner Zetner

Other

Collaborators

  • Copenhagen University Hospital, Denmark
  • Herlev Hospital
  • RepoCeuticals ApS

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 9, 2018
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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