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Long-term data on fertility in humans are lackingand specific studies in subfertile men have not been conductedThe male patients who were planning to father a child were initially excluded from clinical trialsAlthoughanimal studies did not show relevant negative effects on fertilityspontaneous reports of infertility andor poor seminal quality were received post-marketingIn some of these reportspatients had other risk factors that might have contributed to infertilityNormalisation or improvement of seminal quality has been reported after discontinuation of finasteride.

Long-term data on fertility in humans are lackingand specific studies in subfertile men have not been conductedThe male patients who were planning to father a child were initially excluded from clinical trialsAlthoughanimal studies did not show relevant negative effects on fertilityspontaneous reports of infertility andor poor seminal quality were received post-marketingIn some of these reportspatients had other risk factors that might have contributed to infertilityNormalisation or improvement of seminal quality has been reported after discontinuation of finasteride.

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Finasteride for male pattern hair loss has been evaluated for safety in clinical studies involving more than 3,200 menIn three 12-monthplacebo-controlleddouble-blindmulticentre studies of comparable designthe overall safety profiles ofPropeciaand placebo were similarDiscontinuation of therapy due to any clinical adverse experience occurred in 1.7of 945 men treated withPropeciaand 2.1of 934 men treated with placebo.

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With regard to potential finasteride exposure through semen, a study has been conducted in men receiving propecia 1 mg day that measured finasteride concentrations in semen see clinical pharmacology .

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