Introduction Oral treatment with phosphodiesterase type 5 inhibitor (PDE5) is considered the first-line treatment for patients with erectile dysfunction (ED). Lodenafil carbonate (LC) is a novel PDE5. Aim This is a phase II, prospective, randomized, double-blind, and placebo controlled clinical trial of LC. Main Outcome Measures Efficacy end points were International Index of Sexual Function (IIEF) erectile domain, IIEF questions 3 and 4, and Sexual Encounter Profile (SEP) questions 2 and 3, before and after the use of LC or placebo. Methods Seventy-two men older than 18 years, with ED for at least 6 months with stable sexual relationship were enrolled. Patients were randomized to placebo or LC 80 mg, 40 mg, or 20 mg and followed for 4 weeks. Results IIEF erectile domain scores before and after the use of medications were (mean ± standard deviation [SD]): placebo: 11.9 ± 3.4 and 12.6 ± 5.5; LC 20 mg: 15.8 ± 4.1 and 18.9 ± 6.6; LC 40 mg: 11.9 ± 4.4 and 15.4 ± 8.1; LC 80 mg: 14.2 ± 4.7 and 22.8 ± 6.0 (anovaP < 0.01). The SEP-2 scores before and after the use of medications were (Mean ± SD): placebo: 71.0 ± 33.1 and 51.2 ± 43.1; LC 20 mg 70.3 ± 34.2 and 75.5 ± 31.5; LC 40 mg: 48.4 ± 42.1 and 60.8 ± 42.5; LC 80 mg: 68.6 ± 33.5 and 89.6 ± 26.0. The SEP-3 scores were: placebo 23.3 ± 27.6 and 33.6 ± 42.3; LC 20 mg: 32.3 ± 38.9 and 51.2 ± 41.7; LC 40 mg: 39.7 ± 44.7 and 46.7 ± 41.1; LC 80 mg* 17.2 ± 29.5 and 74.3 ± 36.4 (*P < 0.05 for difference to placebo). Conclusions The drug was well tolerated. Adverse reactions were mild and self-limited and included headache, rhinitis, flushing, color visual disorders, and dyspepsia. This study showed that the dosage of 80 mg of LC was significantly more efficacious than placebo and well tolerated.
Self-injection therapy with papaverine, phentolamine and prostaglandin E1 is effective and safe in the treatment of erectile dysfunction after radical prostatectomy.
Introduction: Androgen decline in the aging man has become a topic of increasing clinical relevance worldwide, as the reduction in testosterone levels has been reported to be accompanied by loss of muscle mass, accumulation of central adiposity, impaired mobility and increase risk of bone fractures. Although well-established in studies conducted in developed countries, progressive decline in serum testosterone levels with age has been poorly investigated in Brazil. Aim: To determine the pattern of blood testosterone concentrations decline with age in a cohort of Brazilian healthy military men. Materials and Methods:We retrospectively reviewed data on serum testosterone measurements of healthy individuals that had undergone a routine check-up at the Military Biology Institute. Blood samples were obtained early in the morning, and total testosterone concentration was determined using a commercial chemoluminescent immunoassay. Mean values were analyzed in five age groups: ≤ 40, 41 to 50, 51 to 60, 61 to 70, and > 70 years. Main Outcome Measure: Mean total testosterone levels. Results: 1,623 subjects were included in the analysis; mean age was 57 years (24 to 87), and mean testosterone level was 575.5 ng/dL (25.0 to 1308.0 ng/dL). The evaluation of age-related changes in total testosterone levels revealed a progressive reduction in serum levels of this hormone with increasing age. Testosterone levels below 300 ng/dL were reported in 321 participants, a prevalence of nearly 20% in the study population. Conclusion:In agreement with other findings, a reduction of total testosterone levels with age was reported for healthy Brazilian men.
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