MelatoninPhase 1NCT03519750
Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Melatonin in Healthy Female Volunteers
A Phase 1 study testing Melatonin 25 mg in people with Melatonin and Pharmacokinetics, run by Dennis Bregner Zetner at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melatonin, Pharmacokinetics, Safety
- What is being tested?
- Melatonin 25 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2018to 21 Feb 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female
- 20-40 years old
- BMI 18-30
Who cannot join
- 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)
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Administration of Exogenous Melatonin in Healthy Female Volunteers: a Crossover Study
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
- Being tested
- Melatonin 25 mg
- Keywords
- Melatonin, Safety, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 25 mgDrug
24-48 hour monitoring of plasma melatonin as well as adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous melatonin | Active comparator | Intravenous administration, making it possible to calculate bioavailability for other routes of administration Receives: Drug: Melatonin 25 mg |
| Rectal melatonin | Experimental | Rectal administration of melatonin Receives: Drug: Melatonin 25 mg |
| Intravesical melatonin | Experimental | Intravesical administration of melatonin Receives: Drug: Melatonin 25 mg |
| Vaginal melatonin | Experimental | Vaginal administration of melatonin Receives: Drug: Melatonin 25 mg |
| Transdermal melatonin | Experimental | Transdermal administration of melatonin Receives: Drug: Melatonin 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of melatonin
Plasma concentration of melatonin
Measured: 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
Plasma concentration of melatonin
Measured: 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
Secondary outcomes (2)
Karolinska Sleepiness Scale
Scale which evaluates tiredness of participants
Measured: 0 minutes, once hourly for 8 hours, and again at 24 hours
Simple Reaction Time Test
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.
Measured: 0 minutes, once hourly for 8 hours, and again at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start1 Nov 2018
- Primary completion21 Feb 2019
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelatoninStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dennis Bregner Zetner
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark, RepoCeuticals ApS, Herlev Hospital
- Responsible party
- Sponsor-investigator, Dennis Bregner Zetner, Herlev Hospital
- Investigators
- Dennis B Zetner, MD, Principal investigator, Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519750
- Sponsor's protocol ID
- 2017-000997-13
- Other IDs
- 2017
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2018
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Administration of Exogenous Melatonin in Healthy Female Volunteers: a Crossover Study
- ClinicalTrials.gov ID
- NCT03519750
- Acronym / sponsor ID
- 2017-000997-13
- Conditions
- Melatonin, Pharmacokinetics, Safety
- Keywords
- Melatonin, Safety, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dennis Bregner ZetnerUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark, RepoCeuticals ApS, Herlev Hospital
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intravenous melatonin | Active comparator | Drug: Melatonin 25 mgIntravenous administration, making it possible to calculate bioavailability for other routes of administration |
| Rectal melatonin | Experimental | Drug: Melatonin 25 mgRectal administration of melatonin |
| Intravesical melatonin | Experimental | Drug: Melatonin 25 mgIntravesical administration of melatonin |
| Vaginal melatonin | Experimental | Drug: Melatonin 25 mgVaginal administration of melatonin |
| Transdermal melatonin | Experimental | Drug: Melatonin 25 mgTransdermal administration of melatonin |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy female
- 20-40 years old
- BMI 18-30
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 25 mg24-48 hour monitoring of plasma melatonin as well as adverse events. | Drug | Intravenous melatonin, Intravesical melatonin, Rectal melatonin, Transdermal melatonin, Vaginal melatonin |
Primary outcome
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
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
2 secondary outcomes
Karolinska Sleepiness Scale
Time frame: 0 minutes, once hourly for 8 hours, and again at 24 hours
Simple Reaction Time Test
Time frame: 0 minutes, once hourly for 8 hours, and again at 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis B Zetner, MD principal investigator
Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Melatonin 25 mg in people with Melatonin and Pharmacokinetics, run by Dennis Bregner Zetner at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.