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Pregnancy: Dutasteride is
contraindicated for use by women. Dutasteride has not been studied in women
because pre‑clinical data suggests that the suppression of circulating levels
of dihydrotestosterone may inhibit the development of the external genital
organs in a male foetus carried by a woman exposed to dutasteride.
Lactation: It is not known whether
dutasteride is excreted in breast milk.
Fertility: The
effects of dutasteride 0.5 mg/day on semen characteristics were evaluated in
normal volunteers aged 18 to 52 (n=27 dutasteride, n=23 placebo) throughout 52
weeks of treatment and 24 weeks of post treatment follow-up. At 52 weeks, the mean percent reduction from
baseline in total sperm count, semen volume, and sperm motility were 23%, 26%,
and 18%, respectively, in the dutasteride group when adjusted for changes from
baseline in the placebo group. Sperm concentration and sperm morphology were
unaffected. After 24 weeks of follow-up, the mean percent change in total sperm
count in the dutasteride group remained 23% lower than baseline. While mean
values for all semen parameters at all time points remained within the normal
ranges and did not meet predefined criteria for a clinically significant change
(30%), two subjects in the dutasteride group had decreases in sperm count of
greater than 90% from baseline at 52 weeks, with partial recovery at the
24-week follow-up. The clinical significance of dutasteride's effect on semen
characteristics for an individual patient’s fertility is not known.
