The Clinical Trial of Apomorphine Hydrochloride SL(Uprima(r)) in Patients with Erectile Dysfunction

Park, Hyun Cheol; Park, Hyun Jun; Park, Nam Cheol

Abstract

PURPOSE: The clinical efficacy and safety of apomorphine hydrochloride SL, a new centrally acting oral agent for the management of the male erectile dysfunction (ED), were evaluated.
MATERIALS AND METHODS
Sixty consecutive patients with ED, who visited the Male Sexual Dysfunction Clinic at Pusan National University Hospital, between April and December 2002, were evaluated by open labelled and uncontrolled randomized methods. Apomorphine hydrochloride SL (Uprima(r)), 4-8 3mg tablets, was prescribed on each visit, which was administered sublingually according to the standard patient guidelines. An overall evaluation of erectile function was performed using the international index of erectile function (IIEF) and global efficacy assessment questions (GAQ).
RESULTS
The age distribution of the 51 cases was 22 to 76 years, with a mean of 47.6+/-10.6 years. During the mean follow-up period of 26.2+/-18.6 days, ranging from 7 to 156 days, the sum of the IIEF symptom scores changed significantly, from 11.2+/-6.7, at the baseline, to 17.0+/-8.2, on the 3rd visit (p>0.05). The IIEF scores were significantly improved in the Q3 and Q4, at 45.7% and 59.8%, respectively(p<0.05), while those in the Q6, Q10, Q12 and Q13 were not improved after treatment (p>0.05). The improvements in the IIEF scores revealed in psychogenic and mild grade ED were statistically significance (p<0.05). Selectivity as a treatment regimen was shown in only 5 cases (8.3%). Adverse reactions were noted in 7 cases (13.7%), but were self-limited, and resulted in only 1 (1.9%) drop-out due to dizziness.
CONCLUSIONS
Apomorphine hydrochloride SL is suggested would be a proper oral agent in patients with psychogenic or mild degree organic ED.