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

Completed · Phase 2 · Has a placebo group

Conditions studied: Endometrial Biopsy

In brief

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.

Key facts

Study ID

NCT02465320

Run by

Juniper Pharmaceuticals, Inc.

People needed

187

Starts

2015-05-01

Expected to finish

2016-07-01

Last updated by the study team

2016-07-13

Who can join

Age: 40 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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 Groves, 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
• Women's Clinic of Lincoln PC — Lincoln, Nebraska, United States
• Accent Clinical Trial — Las Vegas, Nevada, United States
• Lawrence OB-GYN Clinical Research, LLC — Lawrenceville, New Jersey, United States
• Albany Medical College — Albany, New York, United States
• New York Center for Women's Health Research — New York, New York, United States
• Carolina Womens Research Wellness Center — Durham, North Carolina, United States
• Unified Women's Clinical Research - Greensboro — Greensboro, North Carolina, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Hawthorne Medical Research Inc. — Winston-Salem, North Carolina, United States
• Lyndhurt Clinical Research (Unified Women's Clinical Research) — Winston-Salem, North Carolina, United States
• Clinical Trials of South Carolina — Charleston, South Carolina, United States
• Physicians Research Options — Draper, Utah, United States
• North Spokane Women's Health — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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