VivaGel® Clinical trials

Completed clinical studies of VivaGel^®

Study No.	Summary	Schedule	No. of Participants
SPL 7013-001	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 7013-003	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 7013-013	Dose ranging for treatment of bacterial vaginosis (BV)	Vaginal administration, once daily for 7 days	132

SPL 7013-015	Phase 3 study for the treatment of bacterial vaginosis (BV)	Vaginal administration, once daily for 7 days	247

SPL 7013-016	Phase 3 study for the treatment of bacterial vaginosis (BV)	Vaginal administration, once daily for 7 days	249

SPL 7013-014	Dose ranging for the prevention of bacterial vaginosis (BV)	Vaginal administration, every other day for 16 weeks	205

Clinical studies in progress of VivaGel^®

Study No.	Summary	Schedule	No. of Participants