Beste apotheek van Nederland

origin). Both trials randomized men to 50 mg gel testosterone (Testim) daily versus 100 mg gel
testosterone (Testim) daily (deliver a daily dose of 5 and 10 mg testosterone, respectively). The
first of these trials included an additional group randomized to 5 mg patch testosterone
(Andropatch), 320 and the second trial randomized two additional groups to 24.4 mg patch
testosterone and placebo. 317
In the first of these trials, 320 men were to remain on their initially assigned treatment dose
throughout the 90 day study, but in the second trial, 317 titration from the initial gel testosterone
dose was possible at 60 days.
Harms. In the first trial, 327 skin irritation was reported by 5.7 percent of men who received
50 mg gel testosterone, 5.3 percent of those who received 100 mg gel testosterone, and 65.8
percent of those who received patch testosterone. Urogenital adverse events (e.g. prostate
enlargement, increased PSA) were reported by 9.6 percent of men who received 50 mg gel
testosterone, 5.1 percent of those who received 100 mg gel testosterone, and 0 percent of those
who received patch testosterone.
In the other two trials, 317,320 approximately 30–35 percent of men who received either of the
gel testosterone groups versus 60 percent of those who received patch testosterone reported at
least one treatment-related adverse event. Most common adverse events were skin application
site reactions and less frequent events were BPH, increase in blood pressure, increase in
hematocrit, gynecomastia, headache, hot flashes, insomnia, mood swings, or spontaneous
erections. The second of these trials 317 reported that withdrawals due to adverse events occurred
in one 50 mg gel testosterone subject, five 100 mg gel testosterone subjects, and 15 patch
testosterone subjects. In the same trial, two patients in the patch testosterone arm were diagnosed
with prostate cancer. 317
Efficacy. In the first trial, 327 patients in the gel testosterone group experienced slightly greater
sexual enjoyment compared with those receiving the testosterone patch (p = 0.0113).
In the second trial, 320 compared with baseline, men in the 50 mg gel testosterone, 100 mg gel
testosterone, and patch testosterone groups experienced 38, 50 and 33 percent improvement in
“sexual performance” (within-group comparison: p <0.05; between-group comparisons: p ≥
0.05). Similarly, all three groups significantly improved from baseline, but without betweengroup
differences for the domains of sexual motivation and sexual desire. Although spontaneous
erections were significantly increased in frequency compared with baseline in both gel
testosterone groups, and not in the patch testosterone group, there were no significant betweentreatment
group differences.
In the third trial, 317 at baseline approximately 20 percent of men reported having no sexual
partner available, and approximately 45 percent reported no sexual intercourse during the past
week. At day 30, among men with sexual partners for whom these data were reported (61 percent
of randomized men), 31 percent of 50 mg gel testosterone men reported an increase from
baseline in the number of days in the past week with sexual intercourse versus 39 percent of 100
mg gel testosterone men (versus 50 mg, p ≥ 0.05, and versus patch, p = 0.03) and 21 percent of
patch testosterone men (versus 50 mg group, p ≥ 0.05).
Gel testosterone versus gel testosterone plus tadalafil. One trial compared the efficacy and
harms of gel testosterone versus gel testosterone plus tadalafil. 231 This trial enrolled 69
hypogonadal men (total testosterone <3.4 ng/ml) aged 34-78 years (mean: 59 years), who had >6
months of ED and a history of nonresponse (i.e. poor IIEF score or persistent patient/partner
dissatisfaction) to 20 mg tadalafil. Men were randomized to 50 mg gel testosterone (Testogel)
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