Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332995
Status:
COMPLETED
Last Update Posted:
2009-09-01
First Post:
2006-06-01
Brief Title:
Safety and Feasibility Study of Dapivirine TMC120 Vaginal Ring in Belgium
Sponsor:
International Partnership for Microbicides Inc
Organization:
International Partnership for Microbicides Inc
Study Overview
Official Title:
Double-blind Randomized Placebo Controlled Trial to Study Safety Local and Systemic Availability of TMC120 From a Vaginal Ring
Status:
COMPLETED
Status Verified Date:
2009-08
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:
This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine TMC120 for 7 days The study population will consist of 13 healthy sexually abstinent women Safety and tolerability will be assessed through clinical and laboratory assessments Feasibility of drug delivery will be assessed by measuring dapivirine TMC120 concentrations in vaginal fluids vaginal and cervical epithelial tissue and plasma
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None