Antiandrogenic treatment of benign prostatic hyperplasia: a placebo controlled trial.

In a randomized triple-blind multicentre study, injections with the anti-androgenic agent oxendolone were compared with placebo in the treatment of benign prostatic hyperplasia. Thirty patients were treated with weekly injections of oxendolone 200 mg during a 3 months' period, and 30 patients were allocated to placebo treatment. During oxendolone treatment the maximum urinary flow rate increased statistically significantly (from 6.8 ml/s to 8.2 ml/s). However compared to placebo, the oxendolone effect was statistically insignificant. A slight but statistically significant improvement of the symptoms "sensation of retention", "urgency" and "frequency", was observed following oxendolone treatment, but an almost identical effect was seen in the placebo group. Following either treatment no change was observed in the residual urine volumes, in prostatic volume as measured by transrectal ultrasonotomography, or in any other therapeutic parameters. Conservative treatment of benign prostatic hyperplasia with the antiandrogen oxendolone in a dose of 200 mg a week cannot be recommended for clinical use.

RCT Entities:   Population Interventions Outcomes