Loading clinical trials...
Loading clinical trials...
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
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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
Yes
Melbourne Sexual Health Centre
Carlton, Victoria, Australia
Start Date
August 1, 2006
Primary Completion Date
February 1, 2007
Completion Date
June 1, 2007
Last Updated
January 16, 2008
36
Estimated participants
3% w/w SPL7013 Gel (VivaGel™)
DRUG
Lead Sponsor
Starpharma Pty Ltd
Collaborators
NCT07071623
NCT04375800
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07209917