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

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.