VivaGel® Clinical trials

Completed clinical studies of VivaGel®

 

Study No.SummaryScheduleNo. 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
       
       

SPL
7013-017

 Phase 3 study for the prevention of bacterial vaginosis (BV) Vaginal administration, every other day for 16 weeks ~600
       

SPL
7013-018

 Phase 3 study for the prevention of bacterial vaginosis (BV) Vaginal administration, every other day for 16 weeks ~600