Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-02-26 @ 6:29 AM
Study NCT ID:
NCT02465320
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2015-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COL-1077 (Lidocaine Bioadhesive Gel, 10%) in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '2015-06-01', 'studyFirstSubmitQcDate': '2015-06-04', 'lastUpdatePostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient subjective assessment of study drug at the end of the study', 'timeFrame': 'up to 48 hours post-endometrial biopsy', 'description': '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)'}, {'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', 'description': 'Incidence of adverse events and serious adverse events'}], 'primaryOutcomes': [{'measure': 'Pain Intensity recorded on the 11-point Numerical Pain Rating Scale (NPRS)', 'timeFrame': 'at the time of endometrial biopsy'}], 'secondaryOutcomes': [{'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', 'description': 'For those who used rescue medication, time to first dose of rescue medication \\& total number of rescue doses used will be determined'}, {'measure': 'Proportion of responders vs. non-responders to COL-1077.', 'timeFrame': 'up to 24 hours post-endometrial biopsy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Endometrial Biopsy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female with an intact uterus, who is ≥ 40 and ≤ 75 years of age\n2. 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\n3. Scheduled to undergo a planned pipelle-directed endometrial biopsy with tenaculum placement\n4. Able to intravaginally self-administer the study drug using the supplied drug applicator and plunger (eg, have adequate manual dexterity)\n5. Willing and able to attend all study visits and complete the pain assessments\n6. Willing to abstain from sexual intercourse 24 hours prior to completion of the endometrial biopsy and for 24 hours following the endometrial biopsy\n7. 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.\n8. Read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization\n\nExclusion Criteria:\n\n1. Pelvic inflammatory disease (PID) within the past 3 months of the Screening Visit (Visit 1) or any ongoing vaginal infection requiring intravaginal treatment\n2. Coagulation disorders\n3. Experiencing daily baseline pelvic or chronic pain\n4. Experiencing menstruation or anticipated menstrual cycle during the study period\n5. Currently using an intrauterine device (IUD) or vaginal ring\n6. Has active vaginal, vulvar or cervical lesions, or cervical or uterine carcinoma\n7. Women who are pregnant or lactating.\n8. Known history of hypersensitivity, allergies or intolerance to lidocaine or other amino amide-type local anesthetics\n9. Known allergy or intolerance to aspirin or non-steroidal anti-inflammatories\n10. Participation in any other investigational drug or device trial within 30 days prior to the Screening Visit (Visit 1)\n11. Regular use of any concomitant medications that might confound efficacy and/or safety assessments\n12. Chronic pain conditions that require regular (eg, daily) use of analgesic and/or anti-inflammatory medications\n13. Use of Class 1 antiarrhythmic or a history of clinically significant cardiac arrhythmia as determined by the investigator\n14. 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\n15. Evidence of current alcohol or drug abuse.'}, 'identificationModule': {'nctId': 'NCT02465320', 'briefTitle': 'COL-1077 (Lidocaine Bioadhesive Gel, 10%) in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Juniper Pharmaceuticals, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'COL-1077-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'COL-1077', 'description': 'lidocaine bioadhesive gel, 10%', 'interventionNames': ['Drug: COL-1077']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo bioadhesive gel', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'COL-1077', 'type': 'DRUG', 'otherNames': ['lidocaine bioadhesive gel, 10%'], 'description': 'single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion', 'armGroupLabels': ['COL-1077']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['bioadhesive gel'], 'description': 'single dose of bioadhesive gel administered by intravaginal insertion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90650', 'city': 'Norwalk', 'state': 'California', 'country': 'United States', 'facility': 'Futura Research', 'geoPoint': {'lat': 33.90224, 'lon': -118.08173}}, {'zip': '80923', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Bluebird Clinical Trials', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Red Rocks OB/GYN', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Medical Research', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33470', 'city': 'Loxahatchee Groves', 'state': 'Florida', 'country': 'United States', 'facility': 'Axcess Medical Research', 'geoPoint': {'lat': 26.68368, 'lon': -80.27977}}, {'zip': '33063', 'city': 'Margate', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Clinical Research Institute', 'geoPoint': {'lat': 26.24453, 'lon': -80.20644}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'New Age Medical Research Corporation', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33162', 'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Ideal Clinical Research', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '30328', 'city': 'Sandy Springs', 'state': 'Georgia', 'country': 'United States', 'facility': 'WR Mount Vernon Clinical Research, LLC', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rosemark Women Care Specialist', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': "Women's Clinic of Lincoln PC", 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Accent Clinical Trial', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Lawrence OB-GYN Clinical Research, LLC', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10038', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "New York Center for Women's Health Research", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27713', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Womens Research Wellness Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': "Unified Women's Clinical Research - Greensboro", 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hawthorne Medical Research Inc.', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': "Lyndhurt Clinical Research (Unified Women's Clinical Research)", 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Trials of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'Physicians Research Options', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'zip': '99207', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': "North Spokane Women's Health", 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Bridget A Martell, MA, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Juniper Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Juniper Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}