Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-04 @ 3:48 AM
Study NCT ID:
NCT03519750
Status:
COMPLETED
Last Update Posted:
2019-04-30
First Post:
2018-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Melatonin in Healthy Female Volunteers
Sponsor:
Dennis Bregner Zetner
Organization:
Study Overview
Official Title:
Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Administration of Exogenous Melatonin in Healthy Female Volunteers: a Crossover Study
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: