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

NCT ID: NCT03519750

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-02-21

Brief Summary

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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

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Conditions

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Melatonin Pharmacokinetics Safety

Keywords

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Melatonin Safety Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intravenous melatonin

Intravenous administration, making it possible to calculate bioavailability for other routes of administration

Group Type ACTIVE_COMPARATOR

Melatonin 25 mg

Intervention Type DRUG

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

Rectal melatonin

Rectal administration of melatonin

Group Type EXPERIMENTAL

Melatonin 25 mg

Intervention Type DRUG

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

Intravesical melatonin

Intravesical administration of melatonin

Group Type EXPERIMENTAL

Melatonin 25 mg

Intervention Type DRUG

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

Vaginal melatonin

Vaginal administration of melatonin

Group Type EXPERIMENTAL

Melatonin 25 mg

Intervention Type DRUG

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

Transdermal melatonin

Transdermal administration of melatonin

Group Type EXPERIMENTAL

Melatonin 25 mg

Intervention Type DRUG

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

Interventions

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Melatonin 25 mg

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Copenhagen University Hospital, Denmark

OTHER

Sponsor Role collaborator

RepoCeuticals ApS

UNKNOWN

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role collaborator

Dennis Bregner Zetner

OTHER

Sponsor Role lead

Responsible Party

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Dennis Bregner Zetner

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dennis B Zetner, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, Denmark

Locations

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Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2017-000997-13

Identifier Type: -

Identifier Source: org_study_id