Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-04-12 @ 4:27 AM
Study NCT ID:
NCT02866227
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2016-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TOL-463 Phase 2 Study for Vaginitis
Sponsor:
Toltec Pharmaceuticals, LLC
Organization:
Study Overview
Official Title:
A Randomized Single Blind Safety and Efficacy Study of TOL-463 Vaginal Gel or Insert in the Treatment of Vaginitis (BV and/or VVC)
Status:
COMPLETED
Status Verified Date:
2018-03
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:
This is a Phase II study designed to assess the safety and efficacy of an investigational product, TOL-463, to treat vaginitis.
Detailed Description:
This is a Phase II randomized single blind safety and efficacy study of TOL-463, administered to female adults to treat vaginitis. Participants will be randomly assigned (1:1) to dose TOL-463 Gel or TOL-463 Insert. Study medication will be administered vaginally, once nightly for seven days. The duration of the study for each participant will be approximately 21-30 days.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HHSN272201300012I | None | None | View |