Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-03-03 @ 12:08 PM
Study NCT ID:
NCT02465320
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2015-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COL-1077 (Lidocaine Bioadhesive Gel, 10%) in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy
Sponsor:
Juniper Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Muticenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Single-Dose of COL-1077 in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy
Status:
COMPLETED
Status Verified Date:
2016-07
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:
The purpose of this study is to determine if COL-1077 (10% lidocaine vaginal bioadhesive gel) will be effective as an acute-use anesthetic and can decrease the pain intensity associated with gynecologic procedures using endometrial biopsy as a representative procedure.
Detailed Description:
COL-1077 is to be self-administered by patients prior to an outpatient transvaginal pipelle-directed endometrial biopsy with tenaculum placement in otherwise healthy women requiring biopsy.
Study Oversight
Has Oversight DMC:
True
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?: