Objective: The relationship between hypogonadism and erectile dysfunction (ED) has not been completely clarified. Data derived from studies evaluating the effect of testosterone (T) replacement therapy (TRT) on patients with ED have yield mixed results. The purpose of the present study was to evaluate the efficacy and safety of a 50 mg/day of 1% hydroalcoholic testosterone gel applied on non-scrotal skin for hypogonadal men with sexual dysfunction.

Material And Methods: We studied a consecutive series of 85 hypogonadal (total testosterone < 12 nmol/L) men (mean age 51.0 +/- 14.0 years) attending our Andrological Unit. Patients were interviewed using ANDROTEST structured interview, a 12-item tool previously validated for the screening of hypogonadism in patients with sexual dysfunction. Patients were also invited to complete erectile function domain of International Index of Erectile Function (IIEF-6;11). Different clinical and biochemical parameters were evaluated at baseline and after 6 months of TRT.

Results: Subjects with ED at baseline (61.2%) showed significant increase of IIEF-6 score after 6 months of TRT (9.7 +/- 7.7 vs. 14.6 +/- 9.8, p < 0.001). Furthermore, subjects with more severe hypogonadism at baseline (T in the lowest quartile) showed the best increase in IIEF-6 score. All haematological and biochemical parameters tested remained in the normal rage at the end of the study.

Conclusions: Our study demonstrated that 1% hydroalcoholic testosterone gel is an effective and safe treatment option in subjects with ED.

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  • * The TRAVERSE study, published in June 2023, found no increased risk of major cardiovascular events in men receiving testosterone therapy compared to a placebo, countering earlier studies that suggested potential risks.
  • * Based on the TRAVERSE findings and extensive previous research, the Androgen Society concludes that testosterone therapy is not linked to higher risks of heart attacks, strokes, or cardiovascular deaths.
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  • Conducted as a single-arm trial with nearly 250 participants over 16 weeks, the study aimed to see if the increase in serum testosterone would significantly affect systolic blood pressure (SBP).
  • The findings indicated a slight rise in average SBP (1.9 mm Hg), but the increase wasn't definitively outside the non-inferiority margin, suggesting that while changes were observed, their clinical significance remains uncertain, particularly among men with hypertension or diabetes.
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