Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00303576
Status:
COMPLETED
Last Update Posted:
2006-07-31
First Post:
2006-03-15
Brief Title:
A Safety and Tolerability Study of Dapivirine TMC120 Vaginal Microbicide Gel
Sponsor:
International Partnership for Microbicides Inc
Organization:
International Partnership for Microbicides Inc
Study Overview
Official Title:
A Phase III Double-Blind Randomized Study of the Safety Tolerability and Systemic Absorption of TMC120 Vaginal Microbicide Gel and Matching Placebo in Healthy HIV-Negative Women
Status:
COMPLETED
Status Verified Date:
2006-07
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:
Approximately 112 HIV-negative women aged 18 to 50 will be enrolled in this multicenter study at four sites Volunteers will be randomized to dapivirine TMC120 vaginal gel or matching placebo gel The volunteers will receive investigational product for a total of 42 days Volunteers will be monitored on days 7 28 and 42 for safety tolerability and compliance
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