VivaGel® Clinical trials
Completed clinical studies of VivaGel®
Study No. | Summary | Schedule | No. of Participants |
---|---|---|---|
SPL |
Safety, tolerability and PK | Vaginal administration, once daily for 7 days | 37 |
SPL 7013-002 |
Safety and acceptability | Topical penile administration, once daily for 7 days | 37 |
SPL |
Vaginal PK, ex vivo antiviral effect | Vaginal administration, 5 doses over 5 weeks | 12 |
SPL 7013-004 |
Expanded safety and tolerability in sexually abstinent women | Vaginal administration, twice daily for 14 days | 54 |
SPL 7013-006 |
Expanded safety and acceptability in sexually active women | Vaginal administration, twice daily for 14 days | 61 |
SPL |
Dose ranging for treatment of bacterial vaginosis (BV) | Vaginal administration, once daily for 7 days | 132 |
SPL |
Phase 3 study for the treatment of bacterial vaginosis (BV) | Vaginal administration, once daily for 7 days | 247 |
SPL |
Phase 3 study for the treatment of bacterial vaginosis (BV) | Vaginal administration, once daily for 7 days | 249 |
SPL |
Dose ranging for the prevention of bacterial vaginosis (BV) | Vaginal administration, every other day for 16 weeks | 205 |
SPL |
Phase 3 study for the prevention of bacterial vaginosis (BV) | Vaginal administration, every other day for 16 weeks | ~600 |
SPL |
Phase 3 study for the prevention of bacterial vaginosis (BV) | Vaginal administration, every other day for 16 weeks | ~600 |