vardenafil-dihydrochloride and testosterone-undecanoate

Long-acting injectable testosterone undecanoate (TU, Nebido(®)), a new parenteral testosterone preparation, has recently been introduced to avoid frequent injections of the conventional injectable esters.. To assess the efficacy and safety of long-acting injectable testosterone undecanoate (TU, Nebido(®)) in Korean patients with testosterone deficiency syndrome (TDS).. One hundred thirty-three patients who complain of erectile dysfunction with serum testosterone level less than 3.5 ng/mL were injected with 1,000 mg of TU (4 mL/ample) on day 1, followed by another injection after 6 weeks and 18 weeks. For the safety profiles, serum hemoglobin (Hb), hematocrit (Hct), glucose, lipid profile, and prostate-specific antigen (PSA) were measured.. Body mass index (BMI) was measured at the time of the first visit and after 12, 24 weeks. Primary efficacy was evaluated according to changes in the International Index of Erectile Function (IIEF) from the initial visit to the final visit (24 weeks) and from the initial visit to each visit. Secondary efficacy was assessed with changes of the Aging Males' Symptoms (AMS) Scale and the Global Efficacy Question (GEQ) for improvement of erectile function.. Mean age of patients was 54 ± 9.6 years. Compared with pretreatment, no significant improvement in BMI was observed. Serum total testosterone and free testosterone were significantly increased at 12 weeks and were maintained until 24 weeks (P < 0.001). TU significantly decreased cholesterol (P < 0.0001). TU significantly improved total IIEF, all five domain scores of IIEF (P < 0.0001) and total AMS, all three domain scores of AMS (P < 0.0001). On GEQ, TU improved erectile function in 76.9% of subjects. On safety profile, TU significantly elevated Hb, Hct, and PSA at 24 weeks but within normal range. No serious adverse reactions were observed. Drop-out rate was 15.0%.. In this prospective multicenter study, TU was effective, safe, and tolerable until 24 weeks in Korean TDS patients. Further well-controlled, long-term study should follow.

Topics: Adult; Aged; Androgens; Cross-Cultural Comparison; Delayed-Action Preparations; Drug Administration Schedule; Drug Therapy, Combination; Erectile Dysfunction; Humans; Hypogonadism; Imidazoles; Korea; Male; Middle Aged; Penile Erection; Phosphodiesterase 5 Inhibitors; Piperazines; Prospective Studies; Sulfones; Testosterone; Triazines; Vardenafil Dihydrochloride

To study effects of different treatments on erectile and endothelial functions in patients with erectile dysfunction (ED) and age-related hypogonadism (HG).. The study included 66 males with ED who had clinical and laboratory signs of HG. All the patients were examined using questionnaires (international index of erectile function, AMS), blood hormones tests. Endothelial function was assessed with postcompression tests on the cavernous arteries and blood homocystein assay. All the patients were divided into two matched groups. Group 1 (20 males, mean age 54.6 +/- 11.5 years) received androgens only, replacement therapy consisted of testosterone undecanoate (Nebido, Shering) 1000 mg each 10-12 weeks intramuscularly, interval between the first and second injection was 6 weeks. Group 2 (46 males, mean age 53.98 +/- 10.03 years) was given combined treatment (androgens and PDE 5 inhibitors), wardenafil (Levitra, Buer Shering Pharma) was used in a dose 20 mg. The treatment lasted 6 months.. AMS points decreased in group 1 from 38.3 +/- 0.29 to 29.2 +/- 0.32, in group 2--from 39.02 +/- 0.21 to 28.6 +/- 0.95, while testosterone rose from 9.86 +/- 0.4 to 17.77 +/- 0.42 and 9.35 +/- 0.25 to 17.21 +/- 0.63 nmol, respectively. Homocystein lowering was significantly more manifest in group 2. EF index in group 2 rose from 11.4 +/- 0.77 to 25.54 +/- 0.25 points versus 11.2 +/- 1.01 to 23.95 +/- 0.71 points in group 1, improvement of EF in group 2 occurred sooner. Endothelial function by diameter of the cavernous arteries differed after treatment in group 1 and 2 (19.55 +/- 2.88 to 39.2 +/- 0.84% and 19.51 +/- 1.28 to 48.5 +/- 1.76, respectively, p<0.001).. Combined therapy improves blood homocistein, acts faster and stronger on endothelial and erectile functions and can be recommended as first line for ED and HG patients.

Topics: Drug Therapy, Combination; Endothelium, Vascular; Erectile Dysfunction; Homocysteine; Humans; Hypogonadism; Imidazoles; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Risk Factors; Sulfones; Testosterone; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

The role of testosterone in erectile dysfunction (ED) is increasingly recognized. It is suggested that assessment of testosterone deficiency in men with ED and symptoms of hypogonadism, prior to first-line treatment, may be a useful tool for improving therapy.. In this prospective, observational, and longitudinal study, we investigated the effects of vardenafil treatment as adjunctive therapy to testosterone undecanoate in hypogonadal ED patients who failed to respond to testosterone treatment alone.. One hundred twenty-nine testosterone deficient (serum total testosterone ≤ 3.4 ng/mL) patients aged 56 ± 3.9 years received intramuscular injections of long-acting parenteral testosterone undecanoate at 3-month intervals for 8 months mean follow-up.. Scores on the International Index of Erectile Function Questionnaire-five items (IIEF-5) and partner survey scores were compared at baseline and posttreatment with testosterone therapy alone or in combination with vardenafil. Patient baseline demographics and concomitant disease were correlated with patients' IIEF-5 scores.. Seventy one (58.2%) responded well to monotherapy within 3 months. Nonresponders had lower testosterone levels and higher rates of concomitant diseases and smoking. Thirty-four of the 51 nonresponders accepted the addition of 20 mg vardenafil on demand. Efficacy assessments were measured by the IIEF-erectile function domain (IIEF-EF, questions 1-5 plus 15, 30 points) and partner self-designed survey at baseline after 4-6 weeks and at study end point. Thirty out of 34 patients responded well to this combination. IIEF-EF Sexual Health Inventory for Men score improved from 12 to 24 (P < 0.0001), and partner survey showed significantly higher satisfaction (P < 0.001). These patients reported spontaneous or nocturnal and morning erections or tumescence. No changes in adverse effects were recorded.. These data suggest that combination therapy of testosterone and vardenafil is safe and effective in treating hypogonadal ED patients who failed to respond to testosterone monotherapy.

Topics: Aged; Aged, 80 and over; Drug Therapy, Combination; Erectile Dysfunction; Female; Humans; Hypogonadism; Imidazoles; Male; Middle Aged; Penile Erection; Personal Satisfaction; Piperazines; Prospective Studies; Sexual Partners; Sulfones; Testosterone; Triazines; Vardenafil Dihydrochloride

This study examined 72 patients with obstructive sleep apnoea syndrome (OSAS), confirmed by polysomnography. Thirty-two patients were suffering from erectile dysfunction (ED) assessed by IIEF-5 questionnaires and confirmed by nocturnal penile tumescence examination. Their testosterone levels were measured. Eight patients had normal testosterone levels and were treated with a PDE-5 inhibitor (vardenafil) only; after 6 months of treatment, 6 of these patients (75%) showed significant improvement in erectile function. The remaining 24 patients with OSAS, ED and hypogonadism (total testosterone <12 nmol l(-1)), were divided into two groups based on the indication for continuous positive airway pressure (CPAP) therapy: five patients received CPAP therapy (group 1) and 19 patients did not (group 2). The patients of group 2 received only a PDE-5 inhibitor (vardenafil 20 mg) for ED; and eight patients (42%) showed an improvement after 3 months of treatment. The five patients receiving CPAP therapy were treated with a combination of parenteral testosterone undecanoate and a PDE-5 inhibitor (vardenafil) and all had normal erectile function after 3 months of therapy. The results suggest positive effects of addition of testosterone to treatment with PDE-5 inhibitors in hypogonadal men with OSAS, which should be confirmed in larger controlled studies.

Topics: Adult; Continuous Positive Airway Pressure; Erectile Dysfunction; Humans; Hypogonadism; Imidazoles; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Pilot Projects; Piperazines; Sleep Apnea, Obstructive; Sulfones; Testosterone; Triazines; Vardenafil Dihydrochloride