Erectile Dysfunction Clinical Trial
Official title:
Effects of Alpha-2 Adrenergic and Opiate Receptor Blockade on Sexual Function in Healthy Male Volunteers
The purpose of this study is to evaluate the safety and effectiveness of the drugs yohimbine
and naltrexone in treating men with erectile dysfunction (ED) (the inability to achieve or
maintain penile erection for satisfactory sexual performance).
ED is a medical and psychological problem that is usually associated with increased age.
Evidence suggests that specific neurotransmitter systems are involved in the regulation of
sexual function. Yohimbine and naltrexone are drugs that may influence these
neurotransmitter systems. This study will use different doses of yohimbine and fixed doses
of naltrexone to determine their effectiveness in treating ED.
Participants in this study will be screened with a medical history, physical examination,
blood and urine tests, and an electrocardiogram (ECG). The study will consist of three
outpatient visists.
Erectile dysfunction (ED) is a relevant medical and psychological problem for males, and is usually associated with increased age. There is substantial evidence available suggesting that noadrenergic and opiate transmitter systems are involved in regulation of sexual function. The objective of the present study is to evaluate the effects and safety of a potential novel treatment combination for ED consisting of both, the alpha-adrenoreceptor antagonist yohimbine, and the opiate antagonist naltrexone. The study uses a three-phase, double-blind, placebo-controlled cross-over design. Healthy, male volunteers will participate. The effects of differing dosages of yohimbine (10 mg versus 20 mg) and a fixed dose of naltrexone (50 mg) on penile tumescene and rigidity, and sexual arousal are assessed in a placebo-controlled design. The anticipated risks of the study are considered minimal in relation to the importance of our increased knowledge about regulation of physiological and psychological aspects of regulation of sexual function and dysfunction. This novel treatment combination could be later also applied to patients with ED of different origin, e.g. organic, psychogenic, and mixed causes. ;
N/A
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