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

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.

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)