drugset / Trial / NCT00700284
Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)
Phase 1
Completed
12 enrolled
International Partnership for Microbicides, Inc.
Tibotec Pharmaceutical Limited · collab
Non-randomizedCrossoverOpen-labelPrevention
Summary
The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.
Timeline
- Start
- 2004-10
- Primary completion
- 2005-01
- Completion
- 2005-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | dapivirine | Small molecule | 120 mg | Other |