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

Endometrial Biopsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465320
• Other study ID #: COL-1077-07
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2015
• Last updated: July 12, 2016
• Start date: May 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Juniper Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Biopsy

Intervention

Drug:
• COL-1077
single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion
• Placebo
single dose of bioadhesive gel administered by intravaginal insertion

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	South Florida Medical Research	Aventura	Florida
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Bluebird Clinical Trials	Colorado Springs	Colorado
United States	Physicians Research Options	Draper	Utah
United States	Carolina Womens Research Wellness Center	Durham	North Carolina
United States	Unified Women's Clinical Research - Greensboro	Greensboro	North Carolina
United States	Rosemark Women Care Specialist	Idaho Falls	Idaho
United States	Red Rocks OB/GYN	Lakewood	Colorado
United States	Accent Clinical Trial	Las Vegas	Nevada
United States	Lawrence OB-GYN Clinical Research, LLC	Lawrenceville	New Jersey
United States	Women's Clinic of Lincoln PC	Lincoln	Nebraska
United States	Axcess Medical Research	Loxahatchee	Florida
United States	South Florida Clinical Research Institute	Margate	Florida
United States	New Age Medical Research Corporation	Miami	Florida
United States	New York Center for Women's Health Research	New York	New York
United States	Ideal Clinical Research	North Miami Beach	Florida
United States	Futura Research	Norwalk	California
United States	Wake Research Associates	Raleigh	North Carolina
United States	WR Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	North Spokane Women's Health	Spokane	Washington
United States	Hawthorne Medical Research Inc.	Winston-Salem	North Carolina
United States	Lyndhurt Clinical Research (Unified Women's Clinical Research)	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Juniper Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Maximum plasma concentration (Cmax)		1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy	No
Other	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	No
Other	Time to maximum concentration ( tmax)		1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy	No
Other	Apparent clearance (CL/F)		1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy	No
Other	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	No
Other	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	Yes
Primary	Pain Intensity recorded on the 11-point Numerical Pain Rating Scale (NPRS)		at the time of endometrial biopsy	No
Secondary	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	No
Secondary	Time-Weighted Average Pain Intensity (TWAPI)		time of tenaculum placement until 2 hours post-endometrial biopsy	No
Secondary	Sum Pain Intensity Difference (SPID)		time of tenaculum placement until 2 & 8 hours post-endometrial biopsy	No
Secondary	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	Yes
Secondary	Proportion of responders vs. non-responders to COL-1077.		up to 24 hours post-endometrial biopsy	No