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Pregnancy: Spedra is not indicated for use in women.
There are no data from the use of avanafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition, or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Breast-feeding: There are no data on the use of avanafil during breast-feeding.
Fertility: There was no effect on sperm motility or morphology after single 200 mg oral doses of avanafil in healthy volunteers.
In a clinical trial performed in healthy volunteers and adult males with mild erectile dysfunction, the daily administration of avanafil 100 mg oral doses over a period of 26 weeks was not associated with any untoward effects on sperm concentration, count, motility, or morphology.
