Dysmenorrhea (Painful Periods)

October 6, 2008

Columbia Labs reported negative results from a phase II trial of lidocaine vaginal gel for the prevention and treatment of dysmenorrhea. This double-blind, placebo-controlled enrolled 70 female subjects with moderate-to-severe dysmenorrhea. The subjects received either lidocaine vaginal gel or placebo in consecutive menstrual cycles. The primary endpoint, the difference between lidocaine and placebo in terms of the time-weighted average patient-assessed pain intensity over four treatment days, was not reached. There was not a significant difference in pain scores between the placebo and lidocaine treatments. Secondary endpoints included a subjective assessment of the treatment at the end of each cycle, and a comparison of the first and second cycles to each other. Analysis of these secondary endpoints is currently underway, however preliminary data showed a trend in favor of the lidocaine cycle. Adverse events were similar between the lidocaine and placebo cycles. Columbia plans to fully analyze the data in order to determine the optimal path for the development of lidocaine vaginal gel.

February 9, 2004

Columbia Laboratories reported positive results from a phase II trial investigating a lidocaine bioadhesive vaginal gel for the treatment of uterine contractions and pain. Results showed that the gel reduced the frequency of uterine contractions, as well as the intensity and frequency of uterine pain. Data demonstrated statistical significance in favor of lidocaine vaginal gel at all time points after vasopressin stimulation for frequency of contractions. In addition, Subjects experienced an overall reduction in the intensity of intra-uterine pressure, intensity of pain and frequency of pain. The single-blind, parallel-group, placebo-controlled trial enrolled 24 subjects with a history of dysmenorrhea. Subjects were evaluated following vasopressin-induced cramping in the late luteal phase of the menstrual cycle.