Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370357
Status:
COMPLETED
Last Update Posted:
2008-01-16
First Post:
2006-08-30
Brief Title:
SPL7013 Gel - Male Tolerance Study
Sponsor:
Starpharma Pty Ltd
Organization:
Starpharma Pty Ltd
Study Overview
Official Title:
A Phase 1 Placebo Controlled Study of the Safety of 3 ww SPL7013 Gel Administered to the Penis of Healthy Male Volunteers Once Daily for Seven Days
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None