Efficacy and safety of daily intake of apomorphine SL in men affected by erectile dysfunction and mild hyperprolactinemia: a prospective, open-label, pilot study.

Objectives: To evaluate the efficacy of the "daily" use of apomorphine SL compared with the "on demand" administration of the drug in patients with mild to moderate erectile dysfunction (ED) and mild hyperprolactinemia who were nonresponders to apomorphine administered "on demand."

Methods: In this open-label prospective study, 34 patients with mild-to-moderate ED and mild hyperprolactinemia were screened. The subjects answered the International Index of Erectile Function (IIEF) questionnaire and underwent follicle-stimulating hormone, luteinizing hormone, testosterone, free testosterone, and prolactin plasma testing, and Doppler sonography at the 2-week screening period to define the ED severity and etiology, at the end of a 4-week "as required" dose-escalation regimen of 2 mg/3 mg apomorphine SL, and at the end of a 4-week period of daily administration of the drug to assess the efficacy of each treatment modality.