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

NCT02465320 | Completed Phase 2 DMC

• 1 other identifier: COL-1077-07
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 23

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.

Conditions

Endometrial Biopsy

Outcome Measures

Primary Outcomes (1)

• Pain Intensity recorded on the 11-point Numerical Pain Rating Scale (NPRS)

  at the time of endometrial biopsy

Secondary Outcomes (5)

• Pain intensity (using 11-point NPRS)

  at the time of tenaculum placement, at the time of insertion of the pipelle, 1 minute following tenaculum removal, 5, 15, 30 and 60 minutes & 2, 6, 8, & 24 hours post-endometrial biopsy

• Time-Weighted Average Pain Intensity (TWAPI)

  time of tenaculum placement until 2 hours post-endometrial biopsy

• Sum Pain Intensity Difference (SPID)

  time of tenaculum placement until 2 & 8 hours post-endometrial biopsy

• Rescue medication usage

  up to 24 hours post-endometrial biopsy

• Proportion of responders vs. non-responders to COL-1077.

  up to 24 hours post-endometrial biopsy

Other Outcomes (7)

• Patient subjective assessment of study drug at the end of the study

  up to 48 hours post-endometrial biopsy

• Maximum plasma concentration (Cmax)

  1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy

• Area under the plasma concentration time curve (AUC) from time 0 to time of last quantifiable concentration (AUC0-last)

  1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy

Study Arms (2)

COL-1077

ACTIVE COMPARATOR

lidocaine bioadhesive gel, 10%

Drug: COL-1077

Placebo

PLACEBO COMPARATOR

placebo bioadhesive gel

Drug: Placebo

Interventions

COL-1077 DRUG

single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion

Also known as: lidocaine bioadhesive gel, 10%

COL-1077

Placebo DRUG

single dose of bioadhesive gel administered by intravaginal insertion

Also known as: bioadhesive gel

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female with an intact uterus, who is ≥ 40 and ≤ 75 years of age
• For those women who are thought to be postmenopausal, postmenopausal will be defined as at least 6 months of confirmed amenorrhea with follicle stimulating hormone (FSH) levels of ≥ 40.0 mIU/mL
• Scheduled to undergo a planned pipelle-directed endometrial biopsy with tenaculum placement
• Able to intravaginally self-administer the study drug using the supplied drug applicator and plunger (eg, have adequate manual dexterity)
• Willing and able to attend all study visits and complete the pain assessments
• Willing to abstain from sexual intercourse 24 hours prior to completion of the endometrial biopsy and for 24 hours following the endometrial biopsy
• Women of childbearing potential must use adequate birth control measures during the course of the study and for at least 7 days after completing study treatment.
• Read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

You may not qualify if:

• Pelvic inflammatory disease (PID) within the past 3 months of the Screening Visit (Visit 1) or any ongoing vaginal infection requiring intravaginal treatment
• Coagulation disorders
• Experiencing daily baseline pelvic or chronic pain
• Experiencing menstruation or anticipated menstrual cycle during the study period
• Currently using an intrauterine device (IUD) or vaginal ring
• Has active vaginal, vulvar or cervical lesions, or cervical or uterine carcinoma
• Women who are pregnant or lactating.
• Known history of hypersensitivity, allergies or intolerance to lidocaine or other amino amide-type local anesthetics
• Known allergy or intolerance to aspirin or non-steroidal anti-inflammatories
• Participation in any other investigational drug or device trial within 30 days prior to the Screening Visit (Visit 1)
• Regular use of any concomitant medications that might confound efficacy and/or safety assessments
• Chronic pain conditions that require regular (eg, daily) use of analgesic and/or anti-inflammatory medications
• Use of Class 1 antiarrhythmic or a history of clinically significant cardiac arrhythmia as determined by the investigator
• History of severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results
• Evidence of current alcohol or drug abuse.

Sponsors & Collaborators

• Juniper Pharmaceuticals, Inc.: lead

Study Sites (23)

Futura Research

Norwalk, California, 90650, United States

Location

Bluebird Clinical Trials

Colorado Springs, Colorado, 80923, United States

Location

Red Rocks OB/GYN

Lakewood, Colorado, 80228, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Axcess Medical Research

Loxahatchee Groves, Florida, 33470, United States

Location

South Florida Clinical Research Institute

Margate, Florida, 33063, United States

Location

New Age Medical Research Corporation

Miami, Florida, 33186, United States

Location

Ideal Clinical Research

North Miami Beach, Florida, 33162, United States

Location

WR Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

Rosemark Women Care Specialist

Idaho Falls, Idaho, 83404, United States

Location

Women's Clinic of Lincoln PC

Lincoln, Nebraska, 68510, United States

Location

Accent Clinical Trial

Las Vegas, Nevada, 89119, United States

Location

Lawrence OB-GYN Clinical Research, LLC

Lawrenceville, New Jersey, 08648, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

New York Center for Women's Health Research

New York, New York, 10038, United States

Location

Carolina Womens Research Wellness Center

Durham, North Carolina, 27713, United States

Location

Unified Women's Clinical Research - Greensboro

Greensboro, North Carolina, 27408, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Hawthorne Medical Research Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Lyndhurt Clinical Research (Unified Women's Clinical Research)

Winston-Salem, North Carolina, 27103, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Physicians Research Options

Draper, Utah, 84020, United States

Location

North Spokane Women's Health

Spokane, Washington, 99207, United States

Location

Study Officials

• Bridget A Martell, MA, MD

  Juniper Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 8, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (23)