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

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ClinicalTrials.gov Identifier: NCT03519750
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : November 26, 2018
Sponsor:
Collaborators:
Copenhagen University Hospital, Denmark
RepoCeuticals ApS
Herlev Hospital
Information provided by (Responsible Party):
Dennis Bregner Zetner, Herlev Hospital

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.

Condition or disease Intervention/treatment Phase
Melatonin Pharmacokinetics Safety Drug: Melatonin 25 mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Administration of Exogenous Melatonin in Healthy Female Volunteers: a Crossover Study
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Active Comparator: Intravenous melatonin
Intravenous administration, making it possible to calculate bioavailability for other routes of administration
Drug: Melatonin 25 mg
24-48 hour monitoring of plasma melatonin as well as adverse events.

Experimental: Rectal melatonin
Rectal administration of melatonin
Drug: Melatonin 25 mg
24-48 hour monitoring of plasma melatonin as well as adverse events.

Experimental: Intravesical melatonin
Intravesical administration of melatonin
Drug: Melatonin 25 mg
24-48 hour monitoring of plasma melatonin as well as adverse events.

Experimental: Vaginal melatonin
Vaginal administration of melatonin
Drug: Melatonin 25 mg
24-48 hour monitoring of plasma melatonin as well as adverse events.

Experimental: Transdermal melatonin
Transdermal administration of melatonin
Drug: Melatonin 25 mg
24-48 hour monitoring of plasma melatonin as well as adverse events.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   They need to be female, in order to receive vaginal administration of melatonin
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519750


Contacts
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Contact: Dennis B Zetner, MD +4527291376 dennis.zetner@gmail.com

Locations
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Denmark
Herlev Hospital Recruiting
Herlev, Denmark, 2000
Contact: Dennis Zetner, MD         
Sponsors and Collaborators
Dennis Bregner Zetner
Copenhagen University Hospital, Denmark
RepoCeuticals ApS
Herlev Hospital
Investigators
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Principal Investigator: Dennis B Zetner, MD Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, Denmark
  Study Documents (Full-Text)

Documents provided by Dennis Bregner Zetner, Herlev Hospital:

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Responsible Party: Dennis Bregner Zetner, Principal Investigator, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03519750     History of Changes
Other Study ID Numbers: 2017-000997-13
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dennis Bregner Zetner, Herlev Hospital:
Melatonin
Safety
Pharmacokinetics

Additional relevant MeSH terms:
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Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants