Ignite Creation Date:
2025-12-18 @ 8:53 AM
Ignite Modification Date:
2025-12-18 @ 8:53 AM
Study NCT ID:
NCT00303576
Status:
None
Last Update Posted:
2006-07-31 00:00:00
First Post:
2006-03-15 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase I/II 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:
None
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: