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

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)

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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