NCT00442910View on ClinicalTrials.gov

Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women

PHASE1CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Healthy
Interventions
DRUG

3% SPL7013 Gel (VivaGel)

3% vaginal gel

DRUG

Placebo Gel

Placebo for SPL7013 gel

DRUG

HEC Placebo Gel

HEC Placebo gel intravaginally bd for 14 days

Trial Locations (3)

33606

University of South Florida, Tampa

15213-3180

Center for Family Planning Research, Magee-Womens Hospital, Pittsburgh

00936-5067

University of Puerto Rico, San Juan

Sponsors
All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

Microbicide Trials Network

NETWORK

lead

Starpharma Pty Ltd

INDUSTRY