Repros Reports Results of Uterine Fibroids Study

Repros Therapeutics announced final results of a U.S. Phase II study of Proellex, an oral drug being developed to relieve symptoms of uterine fibroids. This study suggests that treatment with Proellex results in a highly statistically significant improvement in symptoms associated with uterine fibroids and is generally well tolerated.

This 12-week, double-blind study compared two doses of Proellex, 12.5 and 25 mg, with placebo. The study's primary endpoint was reduction in excessive menstrual bleeding, a common symptom of uterine fibroids. This endpoint was assessed using a validated visual analog scale known as the Pictorial Blood Loss Assessment Chart (PBAC). Pain associated with fibroids was assessed using the McGill pain score, and various other symptoms associated with fibroids were assessed using the validated Uterine Fibroid Symptom and Quality of Life questionnaire.

Of the 127 patients enrolled in the trial, 96 patients completed the study. There were eight premature dropouts in each of the two Proellex arms of the study and 15 dropouts in the placebo arm. There were two dropouts due to an adverse event in the high-dose group as well as one each in both the low-dose and placebo arms.

Women on Proellex experienced a dramatic reduction in PBAC scores from mean scores of greater than 100 to scores of less than 10. The mean scores after three months of dosing for the patients taking the 25- and 12.5-mg dose of Proellex were 6.0 and 16.9, respectively. Women on placebo, on the other hand, exhibited a score of 109.5 after three months of treatment. The 12.5- and 25-mg doses were statistically superior to placebo. These results were similar for both the modified intent-to-treat group and the group of patients that completed the study. A positive effect of reducing menstrual blood loss was a significant increase in hemoglobin in the Proellex-treated group as a whole but particularly in those subjects with abnormally low hemoglobin on study entry.

Women treated with Proellex for three months also experienced an overall highly statistically significant reduction in symptoms associated with uterine fibroids compared with the placebo group. After three months of treatment women on the 12.5- and 25-mg doses of Proellex had scores of 17.4 and 14.9, respectively, compared with 40.1 for the placebo group.