NCT02465320

COL-1077 (Lidocaine Bioadhesive Gel, 10%) in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Juniper Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Biopsy

Interventions

Type	Name	Description
DRUG	COL-1077	single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion
DRUG	Placebo	single dose of bioadhesive gel administered by intravaginal insertion

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-06-08
• Last updated: 2016-07-13

Locations

23 sites across 1 country: United States