Approximately 70 women with a history of moderate-to-severe dysmenorrhea participated in this first documented attempt to show prevention of uterine cramping and pain. This double-blind, placebo-controlled clinical trial used a cross-over design in which each subject received either the lidocaine product candidate or placebo in consecutive menstrual cycles and thus acted as her own control.
The primary endpoint of the study was to show a difference between lidocaine and placebo in terms of the time-weighted average patient-assessed pain intensity over four treatment days.
Data from the clinical trial did not show a significant difference between the pain scores for the lidocaine and placebo treatment cycles. Patients in the clinical trial were also asked to make a subjective assessment of the treatment at the end of each cycle, and to compare the first and second cycles to one another.
While complete analysis of these secondary data is ongoing, top line data suggest a trend for patients to favor their lidocaine treatment cycle. The clinical trial did not reveal any significant adverse events and those adverse events that occurred were similar in both kind and frequency for lidocaine and placebo, the company said.
Robert Mills, president and CEO of Columbia Laboratories, said: “Data from our initial dysmenorrhea clinical study suggest a trend for a positive lidocaine effect among secondary data endpoints for the patients’ overall assessments of each menstrual cycle, although the clinical trial did not show a difference between lidocaine and placebo in patient-assessed pain scores, our primary endpoint.
“We are evaluating if it is feasible to enhance this lidocaine effect through modifications to the dosing regimen and treatment protocol. We are encouraged that the study showed no difference in safety for our lidocaine product candidate compared to placebo. Our next steps will be to conduct a full analysis of these study results and determine the best way to build on these findings.”