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?
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
DR. KAUFMAN: Yes, it was.