In numerous randomised, placebo-controlled clinical trials, phosphodiesterase-5 inhibitors (PDE5Is) have been demonstrated to consistently and significantly improve erectile function (Rosen et al., 2002; Tsertsvadze et al., 2009). As a result, the American College of Physicians' recommendations suggest PDE5Is as the initial treatment for erectile dysfunction (Goldstein et al., 1998; Rosen et al., 2002; Qaseem et al., 2009). Yet, nothing is known about how PDE5Is affect androgen levels in males with low testosterone.
Sildenafil was given as part of the randomized Testosterone and Erectile Dysfunction trial (TED; ClinicalTrials.gov registration number NCT00512707). Here, we go over the hormonal changes brought on by sildenafil treatment (Spitzer et al., 2012). The mean blood total and free testosterone levels in men with erectile dysfunction and low testosterone levels increased significantly and drastically after receiving the recommended dose of sildenafil. Sildenafil may directly affect the testicles, as shown by the contemporaneous drops in blood luteinizing hormone (LH) levels, which accounts for the rise in serum testosterone.
Participants
Men between the ages of 40 and 70 who had erectile dysfunction (International Index of Erectile Function domain score 25) and had serum total testosterone levels below 11.4 nmol/L (330 ng/dL) and/or free testosterone concentrations below 173 pmol/L (50 pg/mL) were eligible to participate (Spitzer et al., 2012). Prostate cancer, creatinine above 180 lmol/L (2 mg/dL), hemoglobin A1c below 8.5%, prostate-specific antigen above 4 ng/mL, blood pressure above 160 mmHg, myocardial infarction within six months, stroke within six months, and congestive heart failure were the exclusion criteria. Other exclusion criteria included the usage of androgens, antiandrogens, nitrates, high-dose opiates, glucocorticoids, and antiepileptic drugs.
Study design
The TED trial was a randomized, double-blind, placebo-controlled, single-center, parallel-group trial that examined the impact of supplementing testosterone therapy with sildenafil citrate at the optimal dose on erectile dysfunction in men with low testosterone (Spitzer et al., 2012). The trial was divided into three phases: screening, open-label sildenafil dose optimization, and intervention. During the intervention phase, individuals were randomly randomized to receive testosterone gel or placebo gel in addition to an optimized sildenafil dose. We have previously published studies of testosterone versus placebo effects on sexual function (Spitzer et al., 2012). (Spitzer et al., 2012).
Sildenafil dose optimization
During the open-label phase, sildenafil was begun and optimized for each participant for a duration of 3 to 7 weeks. Males were typically begun on 50 mg of sildenafil orally once a day, though sildenafil 25 mg was started if people were using an a-adrenergic blocker. Sildenafil 100 mg daily was started on those who had previously taken it. If the erectile response to a lower dose was not satisfactory, men receiving 25 or 50 mg had the option to raise this dose to 100 mg p.o. as necessary for sexual activity (but no more than once in any 24 hours).
Statistical methods
R version 2.15.1 was used to conduct the statistical analysis (R Foundation, Vienna, Austria). ggplot2 library was used to create graphic displays (Wickham, 2009). Paired The strength of the evidence supporting changes in mean hormonal levels when patients were receiving sildenafil monotherapy was evaluated using Student's t-tests. A comparison of the hormonal effects of sildenafil 50 and 100 mg was done using straightforward linear regression.
Sexual behavior
Estimates of self-reported sexual activity levels before and after sildenafil medication were collected using the Male Sexual Health Questionnaire (Rosen et al., 2004).
Sildenafil dose optimization
During the open-label phase, sildenafil was administered to each participant and adjusted for 3–7 weeks. Sildenafil 50 mg p.o. was often the dosage for men. if people took an a-adrenergic blocker, sildenafil 25 mg was started daily. Individuals who said they had previously taken sildenafil 100 mg daily were started on this dosage. Men receiving 25, 50, or 100 mg had the option to increase their dosage. If they were unhappy with the erectile response to a lower dose, they could increase the dosage as necessary for sexual activity (but not more than once in any 24 hours).
Conclusion
Acute sildenafil therapy increased TIF volume while simultaneously boosting testosterone synthesis, which may be important given testosterone's beneficial effects on controlling sexual activity. MM Janjic, NJ Stojkov, MM Bjelic, AI Mihajlovic, SA Andric, and TS Kostic. After giving adult male rats one dose of sildenafil, there was a brief increase in serum testosterone levels.
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