DR. SIMMONS-O'BRIEN: Dr. Kaufman, I have two questions: did
the patients fill out at baseline a sexual function questionnaire?
DR. KAUFMAN: Yes, they did.
DR. SIMMONS-O'BRIEN: And every time the patients were checked
and monitored, did they have to go through a whole point checklist
in terms of sexual function at that particular visit?
DR. KAUFMAN: They would fill out the sexual function questionnaire
at every visit.
DR. SIMMONS-O'BRIEN: At every visit?
DR. KAUFMAN: Yes.
DR. SIMMONS-O'BRIEN: In any of the groups, was there a noticeable
increase or decrease in their sexual activity over the period
that they were on the medication? And did you advise--was there
any advice on the men to use condoms?
DR. KAUFMAN: The sexual function questionnaire in the slide
that I showed previously did show small but statistically significant
changes between the two treatment groups but no effect on the
patients' overall satisfaction with their sex life, and the
changes that were seen were very small compared to patients
who clinically had an adverse event related to sexual function.
I think it's fair to say that there are sporadic reports of
patients who actually report increased libido as well as decreased
libido on finasteride, and the last part of your question was
whether we recommended that patients use condoms. In the Phase
III trials, patients were just discontinued if they fathered
a child, pending additional animal safety data which confirmed
that exposure of women to finasteride through semen was not
a risk to the human fetus.