NCT00370357

SPL7013 Gel - Male Tolerance Study

A Phase 1, Placebo Controlled Study of the Safety of 3% w/w SPL7013 Gel, Administered to the Penis of Healthy Male Volunteers Once Daily for Seven Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (planned)
• Sponsor: Starpharma Pty Ltd · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if SPL7013 Gel (VivaGel™) is safe when applied topically once a day for seven consecutive days to the shaft and glans of the penis in healthy male volunteers. The study will compare the safety of SPL7013 Gel on the penile epithelium and urethral mucosa to the safety of a placebo gel. The study will also assess the systemic safety of SPL7013 Gel, systemic absorption of the active ingredient of SPL7013 Gel, and the acceptability of the study products to the male volunteers.

Conditions

• Human Immunodeficiency Virus (HIV)

Interventions

Type	Name	Description
DRUG	3% w/w SPL7013 Gel (VivaGel™)

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-02-01
• Completion: 2007-06-01
• First posted: 2006-08-31
• Last updated: 2008-01-16

Locations

1 site across 1 country: Australia