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

Phase 2

Completed

• Conditions: Endometrial Biopsy
• Interventions: Drug: Placebo; Drug: COL-1077

• Registration Number: NCT02465320
• Lead Sponsor: Juniper Pharmaceuticals, Inc.

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-08
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 187

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo bioadhesive gel
COL-1077	COL-1077	lidocaine bioadhesive gel, 10%

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time-Weighted Average Pain Intensity (TWAPI)	time of tenaculum placement until 2 hours post-endometrial biopsy
Proportion of responders vs. non-responders to COL-1077.	up to 24 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	For those who used rescue medication, time to first dose of rescue medication \& total number of rescue doses used will be determined
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

Trial Locations

Locations (23)

Futura Research; 🇺🇸 Norwalk, California, United States

Bluebird Clinical Trials; 🇺🇸 Colorado Springs, Colorado, United States

Red Rocks OB/GYN; 🇺🇸 Lakewood, Colorado, United States

South Florida Medical Research; 🇺🇸 Aventura, Florida, 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

Ideal Clinical Research; 🇺🇸 North Miami Beach, Florida, United States

WR Mount Vernon Clinical Research, LLC; 🇺🇸 Sandy Springs, Georgia, United States

Rosemark Women Care Specialist; 🇺🇸 Idaho Falls, Idaho, United States

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