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Clinical Trials/EUCTR2017-000997-13-DK
EUCTR2017-000997-13-DK
Active, not recruiting
Phase 1

Pharmacokinetics of intravenous, rectal, intravesical, vaginal, and transdermal administration of exogenous melatonin in healthy female volunteers: a crossover study

Center for Perioperative Optimization, Department of Surgery, Herlev Hospital0 sites10 target enrollmentNovember 15, 2017
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Center for Perioperative Optimization, Department of Surgery, Herlev Hospital
Enrollment
10
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 15, 2017
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • •Healthy female
  • •20\-40 years old
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 10
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

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

Outcomes

Primary Outcomes

Not specified

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