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

D

Dennis Bregner Zetner

Status and phase

Completed
Phase 1

Conditions

Safety
Pharmacokinetics
Melatonin

Treatments

Drug: Melatonin 25 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT03519750
2017-000997-13

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 5 patient groups

Intravenous melatonin
Active Comparator group
Description:
Intravenous administration, making it possible to calculate bioavailability for other routes of administration
Treatment:
Drug: Melatonin 25 mg
Rectal melatonin
Experimental group
Description:
Rectal administration of melatonin
Treatment:
Drug: Melatonin 25 mg
Intravesical melatonin
Experimental group
Description:
Intravesical administration of melatonin
Treatment:
Drug: Melatonin 25 mg
Vaginal melatonin
Experimental group
Description:
Vaginal administration of melatonin
Treatment:
Drug: Melatonin 25 mg
Transdermal melatonin
Experimental group
Description:
Transdermal administration of melatonin
Treatment:
Drug: Melatonin 25 mg

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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