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Testosterone






Efficacy. The effectiveness of testosterone regarding to improve erectile function and sexual intercourse satisfaction was inconsistent compared with placebo. Differences in patient inclusion criteria (e.g. not all trials were comprised of exclusively of ED patients), methods of evaluation, interventions (e.g. mono versus combination treatment, cream, patch, gel, injections), outcome definitions, and use of subjective measures (e.g. IIEF, SEP), could explain some of the discrepancies in results across the studies evaluating the efficacy of testosterone. The intramuscular administration of testosterone was shown to have improved erectile function compared with placebo in only one of four small trials. The “patch” testosterone did not improve sexual function compared with placebo. However, in men with poor response to previous use of sildenafil, testosterone patch plus sildenafil significantly improved the sexual intercourse success rate and satisfaction compared with placebo and sildenafil alone. Gel testosterone (50 mg and 100 mg doses) was found to have increased sexual intercourse frequency compared with placebo. The 100 mg dose of gel testosterone also significantly improved sexual intercourse frequency versus patch testosterone. The use of combination cream of testosterone, isosorbide dinitrate, and co-dergocrine was associated with an increased rate of successful sexual intercourse and improved erections compared with placebo or cream testosterone alone. The application of dihydrotestosterone gel was related to an increased rate of successful sexual intercourse compared with that of placebo.

Although there is insufficient head-to-head data, the gel formulation of testosterone may be a more effective treatment compared with other formulations of testosterone.

Harms. Patients receiving testosterone patch had a higher rate of having application site skin reactions than those with placebo. The use of gel testosterone did not show a dose-related increase in adverse events. The use of combination cream containing testosterone, isosorbide dinitrate, and co-dergocrine was associated with an increased risk of mild headaches compared with placebo or cream testosterone alone. The short-term followup precluded ascertainment of the incidence of prostate cancer. In one trial, 317 two patients who had been treated with patch testosterone, developed prostate cancer.

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Other Treatments (Off-label use)

For summary of trials refer to Evidence Table F-10 (Appendix F).






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