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.
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Effects of testosterone on quality of life manifest within 3-4 weeks, but maximum benefits take longer.
“Effects on quality of life manifest within 3–4 weeks, but maximum benefits take longer.”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [40]
Effects of testosterone on erythropoiesis are evident at 3 months and peak at 9-12 months.
“Effects on erythropoiesis are evident at 3 months, peaking at 9–12 months.”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [40]
In men with baseline glucose >110 ng/ml (6.6 mmol/l), serum glucose is reduced after 24 weeks of testosterone treatment, but not significantly in men with baseline glucose <110 ng/ml.
“In a recent study, this was observed after 24 weeks only in men with baseline glucose >110 ng/ml (6.6 mmol/l) but not significantly in men whose baseline glucose levels were <110 ng/ml (6.6 mmol/l) (40).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [40]
Increases in IIEF erectile function occur after 3 months, while increases in IIEF sexual desire, intercourse satisfaction, and overall satisfaction appear after 6 weeks.
“Increases in the IIEF erectile function have been noted after 3 months (35, 40) but increases in IIEF sexual desire, intercourse satisfaction, and overall satisfaction appear already after 6 weeks (40).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [40]
Improvements on AMS scores are noted after 1 month, 6 weeks to 3 months, or after 9 months, continuing over a total of 18 months.
“Improvements on scores on the AMS have been noted after 1 month (38), 6 weeks (40) to 3 months on treatment with parenteral testosterone undecanoate (35) or after 9 months on testosterone gel (74) continuing over a total of 18 months (74).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [40]
A rise in prostate-specific antigen levels is found after 3 months in some studies and only after 12 months in others.
“Other studies have found a rise of PSA levels after 3 months (40), some only after 12 months (43).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [40]
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- Authors
- Moon, D. G., Park, M. G., Lee, S. W., Park, K., Park, J. K., Kim, S. W., Park, N. C., Ahn, T. Y., Paick, J. S., Seo, J. T., Yang, D. Y., Lee, J. Y., & Kim, J. J.
- Affiliations
- Korea University (KR)
- Sungkyunkwan University (KR)
- Chonnam National University (KR)
- Jeonbuk National University (KR)
- Catholic University of Korea (KR)
- Pusan National University (KR)
- University of Ulsan (KR)
- Seoul National University (KR)
- Department of Urology, College of Medicine, Kwandong University , Seoul , Korea
- Hallym University (KR)
- Department of Biostatistics, College of Medicine, Korea University , Seoul , Korea
- Corresponding author
- Moon, Du Geon
- ORCID
- Venue
- The Journal of Sexual Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2010-06-01
- Volume
- 7
- Issue
- 6
- Pages
- 2253-2260
- ISSN
- 1743-6095 (ISSN-L)
- 1743-6109
- OpenAlex
- W1920725054
- Cited by
- 46
- References
- 27
- Citations by year
- 2025: 1 · 2023: 2 · 2022: 3 · 2021: 2 · 2020: 1 · 2019: 3 · 2018: 2 · 2017: 6 · 2016: 5 · 2015: 4 · 2014: 2 · 2013: 4 · 2012: 1
- FWCI
- 3.62
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- The Journal of Sexual Medicine (publishedVersion)
- PubMed (publishedVersion)
- Seoul National University Open Repository (Seoul National University) (submittedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Keywords
- testosterone undecanoate, androgen deficiency, erectile dysfunction, Korean patients, International Index of Erectile Function, serum testosterone, hemoglobin and hematocrit, prostate-specific antigen, cholesterol, body mass index, treatment efficacy and safety, testosterone replacement therapy, quality of life
- MeSH terms
- Vardenafil Dihydrochloride, Adult, Aged, Androgens, Cross-Cultural Comparison, Delayed-Action Preparations, Drug Administration Schedule, Drug Therapy, Combination, Humans, Hypogonadism, Imidazoles, Erectile Dysfunction, Korea, Male, Middle Aged, Penile Erection, Piperazines, Prospective Studies, Sulfones, Testosterone, Triazines, Phosphodiesterase 5 Inhibitors
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