This Phase 2b randomized, double-blinded, placebo-controlled, multi-center clinical trial was designed to evaluate the safety and efficacy of COL-1077 10% lidocaine bioadhesive vaginal gel compared to a placebo bioadhesive gel for the reduction of pain intensity in women undergoing pipelle-directed endometrial biopsy with tenaculum placement. The primary efficacy endpoint was reduction in pain intensity at the time of endometrial biopsy on a validated 0-10 Numerical Pain Rating Score (NPRS), with secondary endpoints assessing the reduction in post-procedural pain and cramping over a 24-hour time period.
JNP will now focus on the IVR platform described in #msg-114026617.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”