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Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Oral androgens in the treatment of hypogonadal impotent men.
Journal of Urology 1994 October
A study was designed to assess the effect of supplemental oral methyltestosterone in the treatment of impotence associated with low total serum androgen levels. A total of 22 hypogonadal impotent men underwent a comprehensive investigation of erectile dysfunction, including an evaluation of the pituitary-gonadal axis. The patients then received a 1-month course of 2 different commercial preparations of oral methyltestosterone. Hormonal changes induced by the medication were assessed on days 15 and 30 of treatment. The patients kept daily records of sexual activity, and completed visual analogue scales to assess energy levels, mood and sensation of well being on a weekly basis. Supra-physiological levels of total serum testosterone were achieved in every patient but the free fraction of the hormone did not increase proportionally and in many cases a marked decrease was recorded. In all but 1 subject there was a decrease in circulating sex hormone binding globulin. Pituitary gonadotropin levels showed a marked decrease at the end of treatment. The clinical response was disappointing. Only 9% of the patients reported a complete recovery of sexual function. Visual analogue scales did not reveal noticeable changes for any individual in the levels of energy, mood or feeling of well being between pretreatment and posttreatment assessments. Oral methyltestosterone is of limited effectiveness in men with hypogonadal impotence. The positive responses in this study were recorded in men with the most profound deficiency. Exogenous administration of androgens to impotent men should be limited to those with profound hypogonadism as documented by at least 2 abnormal serum free testosterone determinations.
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