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  PROPECIA FDA HEARING  
 
 
QUESTION 3
 
How does Finasteride affect sperm production and male fertility
 
ANSWER

DR. MINDEL: The drug has an effect on the prostate and the prostate fluid. Is there any evidence of what the effect is on male fertility? You've told all the other hormones and sperm and volume, but the end result, male fertility, has that been looked at?

DR. KAUFMAN: The question has to do with evaluation of male fertility. As I indicated, we've done extensive studies looking at semen analysis, which is a useful marker for looking at any subtle changes that might produce any alterations in male fertility. We obviously have not done a specific fertility study. I think it's appropriate to say, though, that based on the wealth of animal preclinical data, which demonstrates that there is no effect on fertility in animals treated lifelong with chronic high-dose finasteride, based on the semen studies, as I've indicated, showing no effect of the 1-milligram dose over four spermatogenic cycles and based on the limited data that we have on pregnancies that occurred in the clinical trials, which actually were more frequent for patients on finasteride than on placebo, there is no evidence to support that finasteride would have any effect on male fertility.

DR. MINDEL: I would have thought that it would have been relatively easy to have maybe even just done a questionnaire of the males taking the drug, whether they had tried to produce children, placebo versus nonplacebo and have gotten really a more definitive answer to this.

DR. KAUFMAN: I think that in general, at the initiation of some of these trials, there were still issues that may have prohibited patients from fathering children during the clinical trials due to a previous concern about finasteride appearing in the semen. I think that that would have made it more difficult for us to observe pregnancies in these clinical trials.

I think that the issue, though, is that most of these men were not deliberately trying to father children during the one or two year course of these clinical trials, and we presumably would hear if there were difficulties such as infertility as adverse experiences if they were thought that they were related to the study drug, and we have not received those reports.

DR. MCGUIRE: I don't recall; I think it's probably in the briefing book, but was sperm motility one of the measurements of the semen analysis?

DR. KAUFMAN: Yes, it was.

 
   
 
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