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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02465320
Study type Interventional
Source Juniper Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date May 2015
Completion date July 2016

See also
  Status Clinical Trial Phase
Completed NCT01908738 - Effectiveness of Paracervical Block Versus Lidocaine Spray During Endometrial Biopsy N/A
Withdrawn NCT00953641 - Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy Phase 3
Recruiting NCT06180317 - The Effect of Virtual Reality on Anxiety and Pain During Endometrial Biopsy N/A
Recruiting NCT01963819 - Therapeutic Endometrial Biopsy N/A
Completed NCT00200226 - Oral Misoprostol Before Endometrial Biopsy Phase 3