NCT02465320已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 23
- 主要终点
- Pain Intensity recorded on the 11-point Numerical Pain Rating Scale (NPRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
COL-1077
Active Comparator
lidocaine bioadhesive gel, 10%
干预措施: COL-1077 (Drug)
Placebo
Placebo Comparator
placebo bioadhesive gel
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Intensity recorded on the 11-point Numerical Pain Rating Scale (NPRS)
时间窗: at the time of endometrial biopsy
次要结局
- 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)
- 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)
研究者
研究点 (23)
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