Beste apotheek van Nederland

alone. 145 This study enrolled 20 men (mean age: 56 years) with ED of > 6 months and symptoms
of partial androgen deficiency (mean baseline total testosterone 7.3 nmol/L) who partially
responded to previous sildenafil therapy (50-100 mg twice weekly for 2 weeks). The men were
randomized to receive a 2-month treatment with either oral testosterone undecanoate (120 mg
daily) plus sildenafil (50-100 mg) or sildenafil alone. Patients with prostate hypertrophy, prostate
cancer, and mammary carcinoma were excluded.
Harms. Apart from mild headaches occurring in three patients taking sildenafil 100 mg, no
serious adverse events were observed.
Efficacy. At 2 months of followup, the difference in mean IIEF–5 scores between patients
who received the oral testosterone plus sildenafil versus the sildenafil monotherapy groups was
not statistically significant (17.5 versus 15.9, p ≥ 0.05).
Intramuscular Testosterone (IM) versus placebo. Four trials compared the efficacy and
harms of IM testosterone and placebo. 323,325,326,328
In the first trial, 323 nine gonadotropin-deficient males aged 15 years or older (range 16-20)
and currently being treated for hypopituitarism, only 3 of whom had partners, were randomized
to 1 cc IM testosterone enanthate every 2 weeks versus 2000 units human chorionic
gonadotropin three times weekly versus placebo. The active treatment arms each lasted for at
least 6 months, while the placebo treatment lasted for 2 months.
In the second trial, 326 18 men, aged 45-74 years, with ED) were randomized either to IM
testosterone enanthate 200 mg given twice weekly for 6 weeks or IM placebo. Patients with
major disorders, a history of substance abuse, obesity, or major psychopathology were excluded
from the trial.
In the third trial, 325 74 HIV-positive men (CD4 <400), with ED or substantial loss of sexual
desire, with low-to-normal levels of total testosterone (<22.6 nmol/L if the patient had AIDS
plus wasting or fatigue, or otherwise <17.4 nmol/L) and at least one mood symptom of
hypogonadism, were randomized either to IM testosterone cypionate 400 mg given twice daily
for 6 weeks or placebo.
In the fourth trial, 328 32 men ≥ 35 years (mean age: 52 years) with depression and total
testosterone ≤ 350 ng/dL were randomized either to IM testosterone enanthate 200 mg given
once weekly for 6 weeks or IM placebo. Patients with psychiatric disorders or abnormal prostate
exam result (men aged > 50 years) were excluded.
Harms. In two trials, 323,326 no adverse events were reported. In the third trial, 325 men who
received testosterone were more likely to report acne (testosterone: 20.5 percent versus placebo:
0 percent). Differences between men in the testosterone and placebo groups with respect to the
occurrence of irritability (17.9 versus 17.1 percent) and testicular atrophy (5.1 versus 0 percent),
were not statistically significant. In the fourth trial, 328 it was reported that no adverse events
occurred except that one placebo-treated subject had a MI.
Efficacy. In the first trial, 323 weekly frequency of erections in the testosterone and placebo
treatment groups were 7.9 (SD 6.1) and 4.9 (SD 3.3), respectively. The between-group difference
was not statistically significant.
In the second trial, 326 results were based on 12 (67 percent) men who completed all
assessments. At week 6, men in the IM testosterone group reported a median number of “sex
with partner” of 1.25 times per week versus 0.54 times per week for men in the placebo group
(between-group difference: p ≥ 0.05). There was no difference in the degree of erection during
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