From November 2004, 261 patients (mean age 58 years) diagnosed with LOH were treated with long-acting TU (Nebido®, Bayer Pharma, Berlin, Germany) in a prospective observational and longitudinal registry study. All patients gave their written informed consent to be included in the study, which was conducted according to ethical guidelines as formulated by the German ‘Ärztekammer’ (the German Medical Association) for observational studies and followed the principles outlined in the Helsinki Declaration of 1975, as revised in 1983. Men with a TT concentration of ⩽3.5 ng/mL (12 nmol/L) and documented symptoms of ED (Sexual Health Inventory for Men (SHIM) score of ⩽21) met the inclusion criteria. Men received i.m. injections of 1000 mg TU at day 1 (≈3 weeks after diagnosis), week 6 and every 3 months thereafter. Patients were entered into a cumulative registry database once they had received treatment for at least 1 year and followed for up to 5 years. The average treatment period was 4.25 years.
Nebido
Manufactured by Bayer
Sourced in Germany
Nebido is a laboratory equipment product manufactured by Bayer. It is designed for the measurement and analysis of various substances. The core function of Nebido is to provide accurate and reliable data for research and testing purposes.
Automatically generated - may contain errors
Lab products found in correlation
5 protocols using nebido
1
Long-term Testosterone Replacement for LOH
2
Long-term Testosterone Therapy in Hypogonadal Men with CVD
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From two prospective, cumulative observational registries of 622 unselected patients presenting to two urology clinics with hypogonadism (defined as T ≤12.1 nmol/L in the presence of symptoms), we identified 77 men (12.4% of all patients) with a history of CVD. In this subgroup, 77 men with a previous diagnosis of CAD (n=48) and/or a history of myocardial infarction (MI; n=40) and/or stroke (n=7) were analyzed. Mean age at baseline was 61±5 years and mean follow-up time 7.3±1.2 years (minimum: 4 years and maximum: 8 years). All 77 men were continuously treated with testosterone undecanoate (TU) injections (Nebido®; Bayer AG, Leverkusen, Germany) in 3-monthly intervals, following an initial interval of 6 weeks, for up to 8 years. Men were entered into the registry once they had received 1 year of treatment. Inclusion criteria were two separate morning measures of total testosterone ≤12.1 nmol/L and the presence of hypogonadal symptoms measured by the Aging Males’ Symptoms scale (AMS). Exclusion criteria for T administration included previous treatment with androgens, prostate cancer, or any suspicion thereof, such as prostate-specific antigen levels >4 ng/mL or abnormal findings upon digital rectal examination, International Prostate Symptom Score (IPSS) >19 points, breast cancer, recent angina, or severe untreated sleep apnea.
3
Testosterone Depletion and Restoration
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Thirty subjects were submitted to a testosterone depletion by the use of gonadotropin-releasing hormone antagonist (GnRHa) (subcutaneous injection, 240 mg, Degarelix, Ferring Pharmaceuticals, Sweden) and, after three weeks, to an androgen supplementation by use of testosterone undecanoate (intramuscular injection, 1000 mg, Nebido, Bayer Pharmaceuticals, Germany)20 (link).
Therefore, blood samples were collected three times: (i) before TD, corresponding to testosterone and gonadotropins' baseline levels (Basal group); (ii) before the androgen supplementation, relating to low testosterone and gonadotropins' levels (Low group); (iii) two weeks after TS, corresponding to Testosterone restored samples (Restored group) (Fig.1 ).
The naturally recover of testosterone was not applied in this study in order to evaluate what happens in an individual with low gonadotropins and normal testosterone. We assumed that this is a way to study the changes correlated just with testosterone fluctuations. Furthermore, it is important to consider that the testosterone axis recovery period varies significantly among males. Therefore, we believe that this variance would interfere with the last time point metabolic analysis.
Therefore, blood samples were collected three times: (i) before TD, corresponding to testosterone and gonadotropins' baseline levels (Basal group); (ii) before the androgen supplementation, relating to low testosterone and gonadotropins' levels (Low group); (iii) two weeks after TS, corresponding to Testosterone restored samples (Restored group) (Fig.
The naturally recover of testosterone was not applied in this study in order to evaluate what happens in an individual with low gonadotropins and normal testosterone. We assumed that this is a way to study the changes correlated just with testosterone fluctuations. Furthermore, it is important to consider that the testosterone axis recovery period varies significantly among males. Therefore, we believe that this variance would interfere with the last time point metabolic analysis.
4
Long-term Testosterone Therapy in Obese Hypogonadal Men
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From two prospective, cumulative registry studies of 622 hypogonadal men, we identified all 411 obese hypogonadal men (66.1% of all patients) with varying classes of obesity (class I (BMI 30–34.9; n=214, mean age: 58.61±8.04 years), class II (BMI 35–39.9; n=150, mean age: 60.35±5.73 years) and class III (BMI ⩾40 kg m−2; n=47, mean age: 60.51±5.52 years). All men were treated with testosterone undecanoate injections (TU; Nebido, Bayer Pharma, Berlin, Germany) for up to 8 years. Men were entered into the registry once they had received 1 year of treatment. Therefore, registry participants had been in the registry for different durations of time, and declining numbers do not reflect drop-out rates.
Inclusion criteria were two separate morning measures of total testosterone ⩽12.1 nmol l−1 and the presence of hypogonadal symptoms measured by the Aging Males' symptoms scale (AMS).
Exclusion criteria for testosterone administration included previous treatment with androgens, prostate cancer or any suspicion thereof, such as prostate-specific antigen levels >4 ng ml−1 or abnormal findings upon digital rectal examination, International Prostate Symptom Score (IPSS) >19 points, breast cancer, a history of congestive heart failure or recent angina, or severe untreated sleep apnea.
Inclusion criteria were two separate morning measures of total testosterone ⩽12.1 nmol l−1 and the presence of hypogonadal symptoms measured by the Aging Males' symptoms scale (AMS).
Exclusion criteria for testosterone administration included previous treatment with androgens, prostate cancer or any suspicion thereof, such as prostate-specific antigen levels >4 ng ml−1 or abnormal findings upon digital rectal examination, International Prostate Symptom Score (IPSS) >19 points, breast cancer, a history of congestive heart failure or recent angina, or severe untreated sleep apnea.
5
Testosterone Supplementation in Wistar Rats
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T undecanoate was purchased from Bayer Co., Ltd (Nebido®; Seoul, South Korea). T propionate was purchased from Avention Co., Ltd (Incheon, South Korea). Corn oil (Sigma-Aldrich, Korea) was used to dissolve the exogenous testosterone. Male Wistar Hannover rats, weighing 200–250 g, were purchased from Samtako Co., Ltd. (Osan, Republic of Korea) and were acclimatized for at least four weeks to a temperature of 20–24°C, relative humidity of 30–70%, and 12/12-h light/dark cycle. All rats were weighed once per week during the study. The animal studies were performed after receiving approval of the Institutional Animal Care and Use Committee (IACUC) of Sahmyook University (IACUC approval No. SYUIACUC2019-005, SYUIACUC2020-004).
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