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  PROPECIA FDA HEARING  
 
 
QUESTION 5
 
How does Finasteride affect male breast development or gynecomastia
 
ANSWER

DR. SIMMONS-O'BRIEN: Okay; and I just have one more question. In the breast-related experiences in the Phase III controlled trial, you have increased gynecomastia.

DR. KAUFMAN: Yes.

DR. SIMMONS-O'BRIEN: What was your percentage of gynecomastia in the Phase II?

DR. KAUFMAN: Yes; could I have the slide which shows the gynecomastia in Phase II and Phase III? This shows all of the reports of breast-related clinical adverse experiences by dose in both Phase III and Phase II, so, the combined experience. As you recall, for the placebo group in the Phase III experience, there were four cases. So, those were shown here. Four of the finasteride 1 milligram cases are shown here from the Phase III experience, and the remainder of these are from the Phase II experience at a variety of doses.

 
   
 
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