Endometrial Biopsy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGCOL-1077
single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion
DRUGPlacebo
single dose of bioadhesive gel administered by intravaginal insertion
Sponsors
Juniper Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Female with an intact uterus, who is ≥ 40 and ≤ 75 years of age 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Intensity recorded on the 11-point Numerical Pain Rating Scale (NPRS) | at the time of endometrial biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Time-Weighted Average Pain Intensity (TWAPI) | time of tenaculum placement until 2 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 | For those who used rescue medication, time to first dose of rescue medication & total number of rescue doses used will be determined |
| Proportion of responders vs. non-responders to COL-1077. | up to 24 hours post-endometrial biopsy | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient subjective assessment of study drug at the end of the study | up to 48 hours post-endometrial biopsy | 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) |
| Incidence of adverse events and serious adverse events as a measure of Safety and tolerability of COL-1077 | up to 7 calendar days post-study completion | Incidence of adverse events and serious adverse events |
| Maximum plasma concentration (Cmax) | 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy | — |
| Area under the plasma concentration time curve (AUC) from time 0 to time of last quantifiable concentration (AUC0-last) | 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy | — |
| Time to maximum concentration ( tmax) | 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy | — |
| Apparent clearance (CL/F) | 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy | — |
| Terminal elimination half-life (t1/2) | 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy | — |
Countries
United States
Outcome results
None listed