Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-01-26 @ 10:23 PM
Study NCT ID:
NCT01952561
Status:
COMPLETED
Last Update Posted:
2016-08-26
First Post:
2013-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Use PK of Dapivirine Vaginal Ring
Sponsor:
International Partnership for Microbicides, Inc.
Organization:
Study Overview
Official Title:
An Open-label, Parallel-group Pharmacokinetic Trial in Healthy HIV-negative Women to Characterize the Release Profile of Dapivirine Delivered by a Silicone Matrix Ring (Ring 004), Containing 25 mg of Dapivirine, Over Various Ring Use Periods
Status:
COMPLETED
Status Verified Date:
2013-09
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:
Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring containing 25 mg worn for 1, 2, 4, 8 or 12 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: