By Culley C. Carson
This ebook represents a severe appraisal of the foremost medical trials that experience had an important impression on scientific study and perform over the past decade. every one trial follows a strict layout, beginning near to the unique resource of e-book, information at the key investigators and their equipment of analysis. The strengths and weaknesses of every trial are mentioned in addition to their impression on medical perform. Articles are complemented through a diagrammatic precis of the trial layout and the major findings. it truly is anticipated that over 20 million males in Europe by myself undergo at it slow of their lifestyles from erectile disorder (ED). this can be the 1st booklet to assemble in one quantity a serious assessment of the entire significant trials in ED.
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Additional info for Key Clinical Trials in Erectile Dysfunction
6 CONCLUSIONS FROM ORIGINAL REPORTS Intracavernosal alprostadil is an effective and tolerable therapy for men with erectile dysfunction, provided that the optimal dose is established individually and that men are trained in the selfinjection technique with periodic supervision. 7 STRENGTHS This was a large, multicenter, double-blind, placebo-controlled study in 2 conditions. As such, the overall study design would be difﬁcult to fault, even according to the criteria of 2002. An evaluation of the therapeutic ratio of different doses was also undertaken.
American Urological Association 1996. 3 Other Important Publications Engel J, McVary K. Transurethral alprostadil as therapy for patients who withdrew from or failed prior intracavernous injection therapy. Urology 51(5):687–692, 1998. Fulgham P, Cochran J, et al. Disappointing initial results with transurethral alprostadil for erectile dysfunction in a urology practise setting. J Urol 160 (6 Pt 1):2041–2046, 1998. 2 STUDY FUNDING Vivus, Inc. 3 IMPORTANCE OF STUDY In many ways, this trial illustrates the dangers in the interpretation of early clinical trials data.
Of the 10 evaluable patients, 7 were complete responders to apomorphine SL solution, with an RN ≥16 for both erotic and neutral video segments. Six of these patients continued with apomorphine in a domestic trial (duration, 2–7 months), and 3 of them required domperidone pretreatment. • Analysis of the VAS scoring indicated that patients were relaxed, not sedated, and without sexual arousal or anxiety. AEs were reported at both doses of apomorphine. Eight patients experienced typical side effects of unmodiﬁed apomorphine administration (sudden nausea, diaphoresis, dizziness, pallor, visual disturbances, hypotension, and bradycardia), varying in duration from 1 to 40 minutes.