The original Phase II study was a three-month double blind trial comparing 12.5 and 25 mg Proellex to placebo. During the double blind treatment period approximately 80% of the subjects on Proellex 12.5 and 25 mg did not experience menstrual bleeding. The other 20% had very minor intermittent bleeding and no intervention to manage the bleeding was required in this three-month study.
Your post said "Obviously the bleeding during the 4 months was far less than both of those #s." Just to clarify 80% of those women had NO bleeding during the drug cycle, menstrual or otherwise and the other 20% had some spotting, is all.
When they were allowed to menstruate the women had bleeding that was 48% of the baseline - heavy bleeding due to the disease process- so in order to compare to normal they would have originally had double the bleeding of a woman in "normal" cycle terms. Correct?
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