The Efficacy and Safety of Testosterone Undecanoate (Nebido®) in Testosterone Deficiency Syndrome in Korean: A Multicenter Prospective Study

Abstract

Introduction 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. Aims To assess the efficacy and safety of long-acting injectable testosterone undecanoate (TU, Nebido®) in Korean patients with testosterone deficiency syndrome (TDS). Methods 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. Main Outcome Measures 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. Results 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%. Conclusions 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.

Male sexual dysfunction in Asia

“…The results indicated that testosterone undecanoate was effective, safe and tolerable. 55 For premature ejaculation, psychological and behavioural therapy, local anaesthetic creams, SS creams, tramadol and selective serotonin reuptake inhibitors can be used. Dapoxetine, a new short-acting selective serotonin reuptake inhibitor that has fewer side effects than longer-acting selective serotonin reuptake inhibitors, has been recently introduced.…”

Guidelines for the diagnosis and treatment of testosterone deficiency (hypogonadism) in male patients with diabetes mellitus (Draft)

“…Существующие препараты отличаются по пути вве-дения и фармакокинетическим особенностям, решение о выборе конкретного препарата должно приниматься врачом и пациентом совместно [50,51].…”

“…В большинстве ретроспективных исследований был зафиксирован благоприятный эффект в отношении ли-бидо, эрекции и эякуляции (уровень 2a, степень A) [76,77]. Международное многоцентровое проспективное ис-следование с участием 1493 мужчин показало, что ТЗТ достоверно улучшает либидо, эректильную функцию и ответ на терапию ингибиторами фосфодиэстеразы 5-го типа, часто используемыми при лечении ЭД на фоне СД [18,78,79].…”

Testosterone replacement therapy for late-onset hypogonadism: current trends in Korea

“…In a recent prospective study from nine andrological centres involving 133 Korean patients, injectable TU significantly decreased cholesterol, improved total IIEF scores and all five IIEF domain scores, and improved total AMS scores and all three AMS subscales. 39 While TU caused significantly elevated levels of haemoglobin, haematocrit and prostate-specific antigen (PSA) at 24 weeks, serum TT levels were maintained within normal ranges, and no serious adverse reactions were observed.…”

“…In four Korean prospective trials containing data on serial changes in serum PSA levels, two studies found no alterations 34,38 in serum PSA levels, and two studies found significant increases in serum PSA levels after intramuscular TU injection. 39,52 Lee et al 52 followed 47 Korean TRT patients for a mean period of 7.9 months. The patients were classified into two groups based on their initial PSA levels of either above (Group 1) or below 2.5 ng ml 21 (Group 2) PSA.…”