Beste apotheek van Nederland

Hormonal Treatments
Literature Search
There were 20 unique studies (in 20 publications) that met eligibility criteria. 5,77,145,170,231,316­
330 One study was reported in two publications 317,318 and will be referred as Seftel et al. 2004. 317
Two distinct trials were reported in one publication (studies: a and b). 145 The summary of results
for efficacy and harms of two trials 5,77 comparing combination of PDE-5 inhibitors versus PDE­
5 inhibitors alone (and placebo) are presented also in the section for Question 1.
Overview of Trials
Three trials used crossover, 322,323,326 and the remaining 17 used parallel design. Treatment
duration in several trials was 6 months 319,321,323,330 and in one trial 12 months. 316 (Evidence Table
F-9, Appendix 9)
Populations
The mean age of the subjects in the trials was approximately 57 years. Racial characteristics
were reported in only three trials with the majority of the subjects being Caucasians. ED etiology
was physiologic in 89 percent of men, psychogenic in 4 percent, and mixed in 7 percent. Not all
trials were comprised of exclusively patients with ED. 5,77,145,231,322,326,329 Several trials required a
minimum duration of ED for study entry, of 3 months, 5 5 months, 329 or 6 months. 77,145,231,326 Few
trials were comprised of special populations: HIV positive men (n=74), 325 men with major
depressive disorder (n=32), 328 obese men with type 2 diabetes (n=48), 324 and men with
hypopituitarism (n=9). 323
While trials generally enrolled men with hypogonadism and/or andropause, the specific
sexual dysfunction and testosterone entrance criteria across trials varied widely. With respect to
testosterone, all but three trials 145,323,326 mandated that participants have levels below a specified
threshold. Specific entrance criteria regarding total serum testosterone levels varied: 200-350
ng/dl, 322 <300 ng/dL, 317,318,320,327,329 <340-350 ng/dL, 231,328 <400 ng/dL, 5 <436 ng/dL, 324 and
<500 ng/dL. 325 Additional trials required that participants have a low total testosterone (range of
thresholds from 232 to 434 ng/dL) in combination with a low free testosterone, 77 low free
androgen index, 330 a high SHBG, 321 or a free testosterone index between 0.3 and 0.5. 316 (Tables
23-26)
Interventions
Of the 21 trials involving testosterone therapy for treatment of male ED, most assessed
testosterone monotherapy including oral, 145,316,319,324 intramuscular (IM), 325,326,328 gel, 231,317,320,327
patch, 317,320,327,330 and cream forms. 322,329 Five trials studied testosterone in combination with a
phosphodiesterase inhibitor. 5,77,145,231 Two other trials studied a cream combining testosterone,
isosorbide dinitrate and co-dergocrine. 322,329 Finally, one trial compared dihydrotestosterone gel
versus placebo. 321
Study Quality and Reporting
Information on pharmaceutical funding was provided for seven trials. 5,316,317,320,321,327,330 Only
three studies reported using an intention to treat analysis. 5,316,317 Three of the trials reported
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