Prospective randomized study of sexual function in men taking dutasteride for the treatment of androgenetic alopecia

Abstract

Treatment with 5α‐reductase inhibitors has been associated with sexual adverse events such as impotence (erectile dysfunction) and decreased libido. The primary objective of this study was to evaluate adverse events related to sexual function, based on their frequency, duration, persistence and associated treatment discontinuations, in men treated with dutasteride for androgenetic alopecia. Participants were randomized to receive double‐blind dutasteride 0.5 mg or placebo once daily for 24 weeks, followed by open‐label dutasteride 0.5 mg for an additional 24 weeks. Sexual adverse events were followed up until resolution or for up to 24 weeks after the last dose. Overall, 117 men, 23–50 years of age, were randomized. The incidence of sexual adverse events was approximately twofold higher in the dutasteride group (16%) than the placebo group (8%) during the double‐blind period; the overall incidence of sexual adverse events was lower (5%) during the open‐label period. All adverse events were mild to moderate in severity and considered treatment‐related. The adverse events resolved while on study treatment or after the end of treatment and did not lead to treatment discontinuation. A limitation of this study was the small sample size. The sexual adverse events of impotence, decreased libido and ejaculation disorders reported in this study were expected and reversible.

Development of finasteride polymer microspheres for systemic application in androgenic alopecia

“…Dutasteride is approximately three times and 100 times more potent than finasteride for type I and type II, respectively (37). However, ~50% of participants treated with dutasteride for 48 weeks have reported one or more adverse effects, including nasopharyngitis and erectile dysfunction (38,39). Furthermore, studies involving 6,460 patients concluded that dutasteride was effective for improving benign prostate hyperplasia, but was associated with an increased risk of sexual dysfunction (40,41).…”

Efficacy of Intralesional and Oral Dutasteride in the Treatment of Androgenetic Alopecia: A Systematic Review

“…All studies had a minimum intervention of 12 weeks of treatment. After a treatment of at least 24 weeks with oral dutasteride, a significant increase in the mean of the hair count was observed in patients receiving oral dutasteride over placebo (MD: 15.92 hairs [95% CI: 9.87–21.96]; p = <0.00001; I 2 = 90%) [16, 17, 20, 21, 23]. Regarding intralesional dutasteride, only 1 study [18] reported the mean change in hair count and therefore a meta-analysis was not possible; however, a statistically significant difference benefiting the intervention was observed in the mean change of hair count when comparing it to placebo (MD: 7.90 hairs [95% CI: 7.14–8.66]; p = <0.00001) (shown in Figure 3).…”

“…According to the Cochrane RoB 2.0 criteria, 1 study was ranked having a high risk of bias [19] and 3 having some concerns of bias [20][21][22] concerning the randomization process. Subsequently, 3 other studies were ranked as having some concerns of bias [18,19,22] in the deviations from intended intervention domain.…”

“…Based on the data available from the included studies, we compared the mean change in hair count between the intervention (oral or intralesional dutasteride) and its respective control group (placebo) [16][17][18][19][20][21][22][23]. All studies had a minimum intervention of 12 weeks of treatment.…”

Measuring Patient Quality of Life Following Treatment for Alopecia

“…Among these eight studies, the patients were blinded in four. 76,[79][80][81] The patients in the other four studies were aware of the treatment given.…”