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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Endometrial Biopsy

Intervention / Treatment
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* Drug: COL-1077
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |