COL-1077 (Lidocaine Bioadhesive Gel, 10%) in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy
NCT ID: NCT02465320
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
187 participants
INTERVENTIONAL
2015-05-31
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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COL-1077
lidocaine bioadhesive gel, 10%
COL-1077
single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion
Placebo
placebo bioadhesive gel
Placebo
single dose of bioadhesive gel administered by intravaginal insertion
Interventions
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COL-1077
single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion
Placebo
single dose of bioadhesive gel administered by intravaginal insertion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
75 Years
FEMALE
No
Sponsors
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Juniper Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bridget A Martell, MA, MD
Role: STUDY_DIRECTOR
Juniper Pharmaceuticals, Inc.
Locations
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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
Countries
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Other Identifiers
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COL-1077-07
Identifier Type: -
Identifier Source: org_study_id
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