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

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Biopsy
• Intervention / Treatment: Drug: COL-1077; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 187
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Norwalk, California, United States, 90650
      • Futura Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80923
      • Bluebird Clinical Trials
    • Lakewood, Colorado, United States, 80228
      • Red Rocks OB/Gyn
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Loxahatchee, Florida, United States, 33470
      • Axcess Medical Research
    • Margate, Florida, United States, 33063
      • South Florida Clinical Research Institute
    • Miami, Florida, United States, 33186
      • New Age Medical Research Corporation
    • North Miami Beach, Florida, United States, 33162
      • Ideal Clinical Research
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • WR Mount Vernon Clinical Research, LLC
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rosemark Women Care Specialist
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln PC
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Accent Clinical Trial
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrence Ob-Gyn Clinical Research, LLC
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • New York, New York, United States, 10038
      • New York Center for Women's Health Research
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Carolina Womens Research Wellness Center
    • Greensboro, North Carolina, United States, 27408
      • Unified Women's Clinical Research - Greensboro
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Winston-Salem, North Carolina, United States, 27103
      • Hawthorne Medical Research Inc.
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurt Clinical Research (Unified Women's Clinical Research)
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
  • Utah
    • Draper, Utah, United States, 84020
      • Physicians Research Options
  • Washington
    • Spokane, Washington, United States, 99207
      • North Spokane Women's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Female with an intact uterus, who is ≥ 40 and ≤ 75 years of age
2. 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
3. Scheduled to undergo a planned pipelle-directed endometrial biopsy with tenaculum placement
4. Able to intravaginally self-administer the study drug using the supplied drug applicator and plunger (eg, have adequate manual dexterity)
5. Willing and able to attend all study visits and complete the pain assessments
6. Willing to abstain from sexual intercourse 24 hours prior to completion of the endometrial biopsy and for 24 hours following the endometrial biopsy
7. 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.
8. Read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:

1. Pelvic inflammatory disease (PID) within the past 3 months of the Screening Visit (Visit 1) or any ongoing vaginal infection requiring intravaginal treatment
2. Coagulation disorders
3. Experiencing daily baseline pelvic or chronic pain
4. Experiencing menstruation or anticipated menstrual cycle during the study period
5. Currently using an intrauterine device (IUD) or vaginal ring
6. Has active vaginal, vulvar or cervical lesions, or cervical or uterine carcinoma
7. Women who are pregnant or lactating.
8. Known history of hypersensitivity, allergies or intolerance to lidocaine or other amino amide-type local anesthetics
9. Known allergy or intolerance to aspirin or non-steroidal anti-inflammatories
10. Participation in any other investigational drug or device trial within 30 days prior to the Screening Visit (Visit 1)
11. Regular use of any concomitant medications that might confound efficacy and/or safety assessments
12. Chronic pain conditions that require regular (eg, daily) use of analgesic and/or anti-inflammatory medications
13. Use of Class 1 antiarrhythmic or a history of clinically significant cardiac arrhythmia as determined by the investigator
14. 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
15. Evidence of current alcohol or drug abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: COL-1077; lidocaine bioadhesive gel, 10%	Drug: COL-1077; single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion; Other Names: lidocaine bioadhesive gel, 10%
Placebo Comparator: Placebo; placebo bioadhesive gel	Drug: Placebo; single dose of bioadhesive gel administered by intravaginal insertion; Other Names: bioadhesive gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain Intensity recorded on the 11-point Numerical Pain Rating Scale (NPRS)	at the time of endometrial biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	For those who used rescue medication, time to first dose of rescue medication & total number of rescue doses used will be determined	up to 24 hours post-endometrial biopsy
Proportion of responders vs. non-responders to COL-1077.		up to 24 hours post-endometrial biopsy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient subjective assessment of study drug at the end of the study	Patients will be asked to rate the study drug they received for pain by answering the following question. "How would you rate the study drug you received for pain?" Responses are to be recorded as poor (1), fair (2), good (3), or excellent (4)	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
Time to maximum concentration ( tmax)		1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
Apparent clearance (CL/F)		1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
Terminal elimination half-life (t1/2)		1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
Incidence of adverse events and serious adverse events as a measure of Safety and tolerability of COL-1077	Incidence of adverse events and serious adverse events	up to 7 calendar days post-study completion

Collaborators and Investigators

• Sponsor: Juniper Pharmaceuticals, Inc.
• Investigators: Study Director: Bridget A Martell, MA, MD, Juniper Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: COL-1077-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided