Clinical trial NCT02465320: COL-1077 (Lidocaine Bioadhesive Gel, 10%) in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Biopsy
Lead sponsor: Juniper Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-08
Enrollment: 187
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity recorded on the 11-point Numerical Pain Rating Scale (NPRS)
timeFrame: at the time of endometrial biopsy
Secondary outcomes:
measure: Pain intensity (using 11-point NPRS)
timeFrame: 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
measure: Time-Weighted Average Pain Intensity (TWAPI)
timeFrame: time of tenaculum placement until 2 hours post-endometrial biopsy
measure: Sum Pain Intensity Difference (SPID)
timeFrame: time of tenaculum placement until 2 & 8 hours post-endometrial biopsy
measure: Rescue medication usage
timeFrame: up to 24 hours post-endometrial biopsy
measure: Proportion of responders vs. non-responders to COL-1077.
timeFrame: up to 24 hours post-endometrial biopsy
Other outcomes:
measure: Patient subjective assessment of study drug at the end of the study
timeFrame: up to 48 hours post-endometrial biopsy
measure: Maximum plasma concentration (Cmax)
timeFrame: 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
measure: Area under the plasma concentration time curve (AUC) from time 0 to time of last quantifiable concentration (AUC0-last)
timeFrame: 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
measure: Time to maximum concentration ( tmax)
timeFrame: 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
measure: Apparent clearance (CL/F)
timeFrame: 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
measure: Terminal elimination half-life (t1/2)
timeFrame: 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
measure: Incidence of adverse events and serious adverse events as a measure of Safety and tolerability of COL-1077
timeFrame: up to 7 calendar days post-study completion
Locations:
city: Norwalk
country: United States
facility: Futura Research
state: California
city: Colorado Springs
country: United States
facility: Bluebird Clinical Trials
state: Colorado
city: Lakewood
country: United States
facility: Red Rocks OB/GYN
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Loxahatchee
country: United States
facility: Axcess Medical Research
state: Florida
city: Margate
country: United States
facility: South Florida Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: New Age Medical Research Corporation
state: Florida
city: North Miami Beach
country: United States
facility: Ideal Clinical Research
state: Florida
city: Sandy Springs
country: United States
facility: WR Mount Vernon Clinical Research, LLC
state: Georgia
city: Idaho Falls
country: United States
facility: Rosemark Women Care Specialist
state: Idaho
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln PC
state: Nebraska
city: Las Vegas
country: United States
facility: Accent Clinical Trial
state: Nevada
city: Lawrenceville
country: United States
facility: Lawrence OB-GYN Clinical Research, LLC
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: New York Center for Women's Health Research
state: New York
city: Durham
country: United States
facility: Carolina Womens Research Wellness Center
state: North Carolina
city: Greensboro
country: United States
facility: Unified Women's Clinical Research - Greensboro
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurt Clinical Research (Unified Women's Clinical Research)
state: North Carolina
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Draper
country: United States
facility: Physicians Research Options
state: Utah
city: Spokane
country: United States
facility: North Spokane Women's Health
state: Washington
Study officials:
affiliation: Juniper Pharmaceuticals, Inc.
name: Bridget A Martell, MA, MD
role: STUDY_DIRECTOR
References: