drugset / Trial / NCT00136643
Safety, Tolerance and Acceptability Trial of the Invisible Condom® in Healthy Women
Phase 1/2
Completed
452 enrolled
Laval University
Canadian Institutes of Health Research (CIHR) · collabCentre de Recheche du Centre Hospitalier Université Laval · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The objectives of this clinical study are to evaluate the extended safety, tolerance and acceptability of a vaginal gel formulation when applied in 452 healthy women volunteers. This vaginal formulation was shown to be well tolerated in a previous smaller clinical study. The formulation is being developed as a microbicide for the prevention of sexually transmitted infections (STIs) including HIV.
Timeline
- Start
- 2005-06
- Primary completion
- —
- Completion
- 2007-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Lauryl Sulfate | Small molecule | — | Other |