Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring.|
- Safety and tolerability of seven-day use of a vaginal ring containing dapivirine (TMC120).
- Assess dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma during and after seven-day use of a vaginal ring containing dapivirine (TMC120).
|Study Start Date:||July 2005|
|Estimated Study Completion Date:||August 2005|
|Drug Research Unit Gent|
|Gent, Belgium, 9000|
|Principal Investigator:||Dr. Luc Van Bortel||University of Ghent|