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

NCT02465320 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2016-07-13

No results posted yet for this study

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.

Conditions

  • Endometrial Biopsy

Interventions

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

Sponsors & Collaborators

  • Juniper Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Bridget A Martell, MA, MD · Juniper Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02465320 on ClinicalTrials.gov