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Eberhard Nieschlag - One of the best experts on this subject based on the ideXlab platform.

  • androgen receptor gene cag repeat length and body mass index modulate the safety of long term intramuscular Testosterone Undecanoate therapy in hypogonadal men
    The Journal of Clinical Endocrinology and Metabolism, 2007
    Co-Authors: Michael Zitzmann, Eberhard Nieschlag
    Abstract:

    Context: A reliable form of androgen substitution therapy regarding kinetics, tolerance, and restoration of androgenicity is paramount in hypogonadal men. Intramuscular injection of the long-acting ester Testosterone Undecanoate (TU) offers a new modality. Objective: The objective of the study was to assess the safety of TU regarding metabolic and pharmacogenetic confounders. Design: This was a longitudinal one-arm open observation trial. A minimum of five individual assessments was a prerequisite. Putative modulators of safety parameters entering regression models were nadir and/or delta total Testosterone concentrations, body mass index, androgen receptor (AR) gene CAG repeat length, and age. Setting: The study was conducted at an andrological outpatient clinic. Patients: Patients included 66 hypogonadal men (mean age 38 ± 9.9 yr). Main Outcome Measures: A total of 515 data time points each related to prostate, erythropoiesis, lipoproteins, and circulation during 118 treatment-years with 1000 mg TU at 1...

  • clinical experience with the new long acting injectable Testosterone Undecanoate report on the educational symposium on the occasion of the 5th world congress on the aging male 9 12 february 2006 salzburg austria
    The Aging Male, 2006
    Co-Authors: Alvaro Morales, Eberhard Nieschlag, Aksam Yassin, M Schubert, Michael Zitzmann, M Oettel
    Abstract:

    This symposium report summarizes first extensive clinical findings with injectable Testosterone Undecanoate (Nebido®) in hypogonadal patients showing clinical symptoms of androgen deficiency with or without erectile dysfunction (ED). This new Testosterone formulation (1000 mg Testosterone Undecanoate in 4 ml castor oil) possesses nearly ideal long-term kinetics, i.e. sustained close mimicking of eugonadal Testosterone serum levels without supra- or sub-physiological serum concentrations. The generally accepted administration scheme recommends the second injection 6 weeks after the first one followed by further injections every 12 weeks. Applying this regimen, administration intervals are drastically reduced in comparison to conventional i.m. Testosterone preparations (e.g. about 16 injections of Testosterone enanthate vs. 4–5 injections of Testosterone Undecanoate per year). Depending on the Testosterone serum levels, individualized therapy is possible by shortening (every 10 weeks) or prolonging (every 1...

  • treatment of male hypogonadism with Testosterone Undecanoate injected at extended intervals of 12 weeks a phase ii study
    Journal of Andrology, 2002
    Co-Authors: Sigrid Von Eckardstein, Eberhard Nieschlag
    Abstract:

    This paper reports the result of an open-label, non-randomized clinical trial investigating the efficacy and safety of an injectable preparation of Testosterone Undecanoate (TU) dissolved in castor oil and given over a 3.2-year period. In a previous study we demonstrated that injections of TU every 6 weeks resulted in satisfactory substitution but a tendency toward Testosterone accumulation. Here we investigate prolonged TU treatment at extended injection intervals in 7 hypogonadal men. Injections were given at gradually increasing intervals between the fifth and 10th injection, and from then on every 12 weeks. Steady state kinetics were obtained after the 13th injection. Well-being, sexual activity, clinical chemistry, prostate volume, and prostate-specific antigen (PSA) and serum hormone levels were monitored. Patients were clinically well-adjusted throughout the study. Before the next injection, Testosterone, dihydroTestosterone, and estradiol levels were mostly within the normal range and showed a tendency to decrease with increasing injection intervals. Body weight, hemoglobin, serum lipids, PSA, and prostate volume did not change significantly during the 3.2 years of treatment. PSA levels were always within the normal limit. Maximal Testosterone levels during steady state kinetics were measured after 1 week with 32.0 +/- 11.7 nmol/L (mean +/- SD). Before the last injection, mean Testosterone concentrations were 12.6 +/- 3.7 nmol/L. Compared with conventional Testosterone enanthate or cypionate treatment requiring injection intervals of 2-3 weeks and resulting in supraphysiological serum Testosterone levels, injections of TU at intervals of up to 3 months offer an excellent alternative for substitution therapy of male hypogonadism.

  • an effective hormonal male contraceptive using Testosterone Undecanoate with oral or injectable norethisterone preparations
    The Journal of Clinical Endocrinology and Metabolism, 2002
    Co-Authors: Axel Kamischke, Sigrid Von Eckardstein, Tanja Heuermann, Kathrin Kruger, Ilka Schellschmidt, Alexander Rubig, Eberhard Nieschlag
    Abstract:

    Suppression of spermatogenesis to azoospermia is the goal of hormonal male contraception based on T combined with gestagens. The combination of the long-acting T, ester Testosterone Undecanoate (TU), with norethisterone (NET) enanthate (E) showed high efficacy. In the present study, we tested the validity of this approach by varying the NET dose and mode of application. The aim of the study was to achieve high rates of suppression of spermatogenesis as reflected by sperm counts, monitor gonadotropins as well as other hormones, and evaluate any possible side effects. In a phase II clinical trial, groups of normal volunteers received: 1000 mg TU im at wk 2, 6, 12, and 18 combined with 200 mg NETE im at wk 0, 6, 12, and 18 (group I); 1000 mg TU im and 400 mg NETE im at wk 0, 6, 12, and 18 (group II); and 1000 mg TU im at wk 0, 6, 12, and 18 with daily oral NET acetate (NETA) from wk 0 to 24 (group III). In all groups marked suppression of gonadotropins resulted in a significant decrease of spermatogenesis an...

  • intramuscular Testosterone Undecanoate and norethisterone enanthate in a clinical trial for male contraception
    The Journal of Clinical Endocrinology and Metabolism, 2001
    Co-Authors: Axel Kamischke, Sigrid Von Eckardstein, Stefan Venherm, Daniela Ploger, Eberhard Nieschlag
    Abstract:

    Recent trials for hormonal male contraception are based on gestagens or GnRH antagonists combined with oral or injectable Testosterone substitution. However, the efficacy of most trials remained disappointing. Norethisterone enanthate (NETE) has been used as a long-acting injectable female contraceptive and has shown sustained suppression of spermatogenesis in male monkeys and prolonged suppression of gonadotropins in men. This study was designed to prove the efficacy of the long-acting Testosterone Undecanoate ester (TU) alone or in combination with NETE in a phase II clinical trial. Fourteen healthy men received injections of 1000 mg TU in combination with injections of 200 mg NETE every 6 weeks over a period of 24 weeks, followed by a control period of 28 weeks. Another 14 volunteers received TU alone. During the study semen variables, reproductive hormones, clinical chemistry and lipid parameters, well-being, and sexual function were monitored. Scrotal content and prostates were checked sonographicall...

Ronald S Swerdloff - One of the best experts on this subject based on the ideXlab platform.

  • a new oral Testosterone Undecanoate therapy comes of age for the treatment of hypogonadal men
    Therapeutic Advances in Urology, 2020
    Co-Authors: Ronald S Swerdloff, Robert E Dudley
    Abstract:

    Background:A novel formulation of oral Testosterone Undecanoate (TU) was studied in a long- and short-term phase III trial to evaluate safety and efficacy.Methods:Hypogonadal men (age 18–65 years; ...

  • steady state pharmacokinetics of oral Testosterone Undecanoate with concomitant inhibition of 5α reductase by finasteride
    International Journal of Andrology, 2011
    Co-Authors: Mara Y Roth, Ronald S Swerdloff, Christina Wang, Robert E Dudley, Laura Hull, Andrew Leung, P Christenson, John K Amory
    Abstract:

    Oral Testosterone Undecanoate (TU) is used to treat Testosterone deficiency; however, oral TU treatment elevates dihydroTestosterone (DHT), which may be associated with an increased risk of acne, male pattern baldness and prostate hyperplasia. Co-administration of 5α-reductase inhibitors with other formulations of oral Testosterone suppresses DHT production and increases serum Testosterone. We hypothesized that finasteride would increase serum Testosterone and lower DHT during treatment with oral TU. Therefore, we studied the steady-state pharmacokinetics of oral TU, 200 mg equivalents of Testosterone twice daily for 7 days, alone and with finasteride 0.5 and 1.0 mg po twice daily in an open-label, three-way crossover study in 11 young men with experimentally induced hypogonadism. On the seventh day of each dosing period, serum Testosterone, DHT and oestradiol were measured at baseline and 1, 2, 4, 8, 12, 13, 14, 16, 20 and 24 h after the morning dose. Serum Testosterone and DHT were significantly increased into and above their normal ranges similarly by all three treatments. Co-administration of finasteride at 0.5 and 1.0 mg po twice daily had no significant effect on either serum Testosterone or DHT. Oral TU differs from other formulations of oral Testosterone in its response to concomitant inhibition of 5α-reductase, perhaps because of its unique lymphatic route of absorption.

  • pharmacokinetics and safety of long acting Testosterone Undecanoate injections in hypogonadal men an 84 week phase iii clinical trial
    Journal of Andrology, 2010
    Co-Authors: Christina Wang, Adrian S Dobs, Mark Harnett, Ronald S Swerdloff
    Abstract:

    Currently available Testosterone (T) injections in the United States are administered at 2-3 weekly intervals. Less frequent injections with favorable serum T pharmacokinetics would benefit hypogonadal men. The objective of this study is to assess the pharmacokinetics of long-acting Testosterone Undecanoate (TU) intramuscular (IM) injection in hypogonadal men. An unblinded, multicenter phase 3 clinical trial was conducted in 31 academic centers and contract research organizations. Males (130) more than 18 years of age with serum total T < 300 ng/dL were enrolled and received 750-mg injections of TU at weeks 0 and 4 and every 10 weeks thereafter for 9 injections over 84 weeks. The main outcome variables were serum total T, free T, dihydroTestosterone (DHT), estradiol (E(2)) levels, and safety parameters. After the first injection, patients maintained average trough T concentrations in the adult male range (300-1000 ng/dL or 10.4-34.7 nmol/L) before each injection and at multiple time points measured after the third and fourth injections. Serum free T, DHT, and E(2) levels and their ratios to serum T remained relatively consistent once steady state was attained. TU injections were generally well tolerated, with safety profiles similar to other T replacement. We conclude that hypogonadal patients treated for 84 weeks with a 750-mg IM injection of TU every 10 weeks demonstrated average concentrations of T, its metabolites (DHT and E(2)), and ratios--DHT:T and E(2):T--within the adult male reference range at all time points measured. TU injections would be an acceptable alternative to the currently available 2-3 weekly injectables.

  • long acting Testosterone Undecanoate therapy in men with hypogonadism results of a pharmacokinetic clinical study
    The Journal of Urology, 2008
    Co-Authors: Abraham Morgentaler, Adrian S Dobs, Joel M Kaufman, Martin Miner, Ridwan Shabsigh, Ronald S Swerdloff, Christina Wang
    Abstract:

    Purpose: We determined the pharmacokinetics and safety of 750 mg long acting Testosterone Undecanoate given intramuscularly at 0, 4 and 14 weeks to men with hypogonadism.Materials and Methods: A 24-week, single arm, open label, multicenter trial in 130 hypogonadal men 18 years or older who were screened for serum total Testosterone less than 300 ng/dl was performed at 31 research sites in the United States between March and November 2007. Testosterone Undecanoate (750 mg) was administered at baseline, and at weeks 4 and 14. Serum Testosterone samples were collected on days 4, 7, 11, 14, 21, 28, 42, 56 and 70 following injection 3. Safety was assessed, eg biochemical markers and adverse events, secondary to Testosterone Undecanoate treatment.Results: Of the 130 patients 116 with a mean ± SE age of 54.2 ± 0.90 years completed the 24-week trial. Following the week 14 injection mean ± SD average serum Testosterone was 494.9 ± 141.46 ng/dl during the 70-day dosing interval and mean ± SD maximum serum testoster...

  • pharmacokinetics of Testosterone Undecanoate injected alone or in combination with norethisterone enanthate in healthy men
    Journal of Andrology, 2006
    Co-Authors: Ammar Qoubaitary, Ronald S Swerdloff, S. Cerpolini, Cristina M Meriggiola, Giuseppe Pelusi, Laura Hull, Leslie Lumbreras, Peter D Christensen, Christina Wang
    Abstract:

    Long-acting injectable Testosterone Undecanoate (TU) is a promising androgen for male hormonal contraception. As a prerequisite for a planned multicenter male contraceptive efficacy study, we studied the pharmacokinetics of 2 doses of TU alone or in combination with norethisterone enanthate (NETE) in a prospective 2-center study, randomized for TU dose in each center. Twenty healthy male volunteers in each center were administered intramuscular injections of 750 or 1000 mg TU alone or in combination with 200 mg of NETE IM every 8 weeks for 3 injections. There were no significant differences in maximum concentration and area under the curve (AUC) for serum total and free Testosterone (T) between the TU 750 and 1000 mg groups, irrespective of whether TU was administered with 200 mg of NETE. TU 1000 mg IM alone or with NETE at 8-weekly intervals resulted in linear increases in average concentration and AUC of serum total and free T with each injection. Accumulation ratios of serum total and free T levels (calculated as 8 weeks post- to preinjection levels) for each period showed significant increases in the TU+ NETE groups. Serum gonadotropins levels and sperm concentration were more consistently suppressed in the TU 1000 mg + NETE group. We conclude that despite some accumulation of T, TU 1000 mg + NETE 200 mg administered every 8 weeks may be preferable for the future contraceptive efficacy study because of more complete suppression of gonadotropins and spermatogenesis.

W. J. Bremner - One of the best experts on this subject based on the ideXlab platform.

  • Testosterone Undecanoate Maintains Spermatogenic Suppression Induced by Cyproterone Acetate Plus Testosterone Undecanoate in Normal Men
    2016
    Co-Authors: M. C. Meriggiola, A. Costantino, S. Cerpolini, W. J. Bremner, D. Huebler, A. M. Morselli-labate, B. Kirsch, A. Bertaccini, C. Pelusi, G. Pelusi
    Abstract:

    In this study we evaluated whether Testosterone Undecanoate (TU), alone or combined with low dose cyproterone acetate (CPA), can maintain spermatogenic suppression induced by higher doses of CPA plus TU. Twenty-four men received for 12 wk 20 mg/d CPA plus 1000 mg/6 wk TU and then 1000 mg/8 wk TU plus 20 mg/d CPA (n8), 2 mg/d CPA (n8), or plus placebo (n 8) for 32 wk. Blood samples, physical examinations, hor-mones, chemistry, hematology, semen analysis, and sexual/ behavioral assessments were performed throughout the study. Sperm counts decreased to less than 1 million/ml in all subjects by wk 12, and 54 % of them achieved azoospermia. Suppression of sperm counts was maintained until wk 44. Serum LH and FSH levels were suppressed by wk 12 of hor-mone administration and remained suppressed until wk 44. No significant changes in any biochemical parameters wer

  • acceptability of an injectable male contraceptive regimen of norethisterone enanthate and Testosterone Undecanoate for men
    Human Reproduction, 2006
    Co-Authors: Cristina M Meriggiola, S. Cerpolini, W. J. Bremner, Michael Mbizvo, Kirsten M Vogelsong, Giuseppe Martorana, Giuseppe Pelusi
    Abstract:

    We assessed attitudes towards and acceptability of male hormonal contraception among volunteers participating in a clinical trial of a prototype regimen consisting of progestin and Testosterone injections. After completing screening eligible men were randomly assigned to the no-treatment group (n = 40) or to receive injections of norethisterone enanthate and Testosterone Undecanoate or placebo at different intervals (n = 50) according to a blocked randomization list. They underwent self-administered questionnaires. The average age of the participants was approximately 28 years; most were involved in a stable relationship and had no children. Ninety-two percentage of the respondents thought that men and women should share responsibility for contraception and 75% said they would try a hormonal contraceptive if available. At the end of the treatment phase 66% of the participants said that they would use such a method and most rated its acceptability very highly; none reported it to be unacceptable. The injections themselves were indicated as the biggest disadvantage. No significant changes in sexual function or mood states were detected among the men who underwent hormone injections. The contraceptive tested in this study was well accepted by the participants over the course of 1 year. (authors)

  • norethisterone enanthate plus Testosterone Undecanoate for male contraception effects of various injection intervals on spermatogenesis reproductive hormones testis and prostate
    The Journal of Clinical Endocrinology and Metabolism, 2005
    Co-Authors: M. C. Meriggiola, A. Costantino, W. J. Bremner, A. Bertaccini, F Saad, Laura Demidio, A Morselli M Labate, I Rudolph, M Ernst, B. Kirsch
    Abstract:

    The goal of this study was to find the most favorable injection interval of norethisterone enanthate (NETE) plus Testosterone Undecanoate (TU) in terms of gonadotropin, sperm suppression, and prostatic effects. Fifty normal men were randomly assigned to receive NETE 200 mg plus TU 1000 mg every 8 wk (n = 10), every 12 wk (n = 10), every 6 wk for 12 wk and then every 12 wk (n = 10), and every 6 wk for 12 wk and thereafter TU 1000 mg plus placebo every 12 wk (n = 10), and placebo plus placebo every 6 wk for 12 wk and then every 12 wk (n = 10) for 48 wk. Semen analyses, blood drawings, physical examinations, and prostate ultrasounds were performed throughout the study. Of the men in the 8-wk injection group, 90% (nine of 10) achieved azoospermia, compared with 37.5% (three of eight) in the 12-wk injection group (P = 0.019). TU plus placebo injected every 12 wk did not maintain sperm suppression. Prostate volumes did not change significantly in either group. In conclusion, these data suggest that the combined administration of NETE and TU at 8-wk intervals represents an effective hormonal contraceptive regimen.

  • male hormonal contraception suppression of spermatogenesis by injectable Testosterone Undecanoate alone or with levonorgestrel implants in chinese men
    Journal of Andrology, 2004
    Co-Authors: Youlun Gui, W. J. Bremner, John K Amory, Exiang Zheng, Jie Yang, Peijuan Yang, Ersheng Gao
    Abstract:

    Monthly injections of Testosterone Undecanoate (TU) act as a male contraceptive by reversibly suppressing spermatogenesis to azoospermia or severe oligoazoospermia in 95% of Chinese men. In 5% of Chinese men, however, monthly TU administered alone fails to suppress spermatogenesis into contraceptive ranges, or sperm "rebound," leading to occurrences of pregnancy during treatment. Since combinations of progestins and androgens are associated with greater degrees of sperm suppression in white men, we hypothesized that the combination of TU and the progestin levonorgestrel (LNG) would result in improved spermatogenic suppression in Chinese men. Sixty-two healthy Chinese men were randomly assigned to one of the following 3 regimens: group I (n = 21) received 4 LNG rods (75 mg each), which were followed 4 weeks later by 500 mg of TU by intra-muscular (IM) injection every 8 weeks for 24 weeks; group II (n = 20) received 4 LNG implants, which were followed 4 weeks later by 1000 mg of TU by IM injection every 8 weeks for 24 weeks; and group III (n = 21) received TU 1000 mg by IM injection every 8 weeks for 24 weeks. Sperm counts, serum Testosterone (T), luteinizing hormone, follicle-stimulating hormone, and LNG were measured every 2 weeks before, during, and after treatment. During treatment, group II demonstrated a trend toward a greater attainment of azoospermia than groups I and III (90% vs 62% [group I] vs 67% [group III]; P =.09). Attainments of either azoospermia or oligozoospermia (sperm density, .05 for comparisons between groups). Spermatogenesis in all subjects returned to the normal range after the implants were removed. No serious adverse events and no significant changes in serum chemistry occurred during the study. These results demonstrate that the combination of IM injections of high-dose TU every 2 months and LNG implants is associated with marked suppression of spermatogenesis in Chinese men. The combination of high-dose TU every 2 months and LNG implants is a promising candidate for future large-scale efficacy studies of hormonal male contraception in Chinese men.

  • male hormonal contraception effects of injections of Testosterone Undecanoate and depot medroxyprogesterone acetate at eight week intervals in chinese men
    The Journal of Clinical Endocrinology and Metabolism, 2004
    Co-Authors: Jiansun Tong, Xinghai Wang, Dong Yuan, Wenhao Tang, W. J. Bremner
    Abstract:

    Surveys indicate that one form of acceptable male hormonal contraception would consist of injections given at 2- to 3-month intervals. This report describes a study of depot medroxyprogesterone acetate (DMPA) and Testosterone Undecanoate (TU) injected at 8-wk intervals for suppression of spermatogenesis in healthy Chinese men. After screening, 30 healthy volunteers were enrolled and randomly assigned to one of three dose groups (n = 10/group): 1000 mg TU (group A); 1000 mg TU plus 150 mg DMPA (group B); 1000 mg TU plus 300 mg DMPA (group C). All doses were given as im injections at 8-wk intervals. The study consisted of an 8-wk control (baseline) period, a 24-wk treatment period, and a 24-wk recovery period. Consistent azoospermia or severe oligozoospermia was achieved and maintained in all volunteers during the treatment period, except for two men in the TU-alone group who experienced a rebound in sperm concentrations. An 8-wk regimen of TU plus DMPA at both tested combination doses effectively suppressed spermatogenesis to azoospermia in Chinese men. All volunteers tolerated the injections; no serious adverse effects were reported. The lower-dose combination is recommended for further testing in an expanded clinical trial or contraceptive efficacy study.

G Dimitriadis - One of the best experts on this subject based on the ideXlab platform.

  • metabolic phenotype of male obesity related secondary hypogonadism pre replacement and post replacement therapy with intra muscular Testosterone Undecanoate therapy
    Endocrine, 2018
    Co-Authors: G Dimitriadis, Harpal S Randeva, Saboor Aftab, Asad Ali, John Hattersley
    Abstract:

    To explore the metabolic phenotype of obesity-related secondary hypogonadism (SH) in men pre-replacement and post-replacement therapy with long-acting intramuscular (IM) Testosterone Undecanoate (TU). A prospective observational pilot study on metabolic effects of TU IM in male obesity-related SH (hypogonadal [HG] group, n = 13), including baseline comparisons with controls (eugonadal [EG] group, n = 15). Half the subjects (n = 7 in each group) had type 2 diabetes mellitus (T2D). Baseline metabolic assessment on Human Metabolism Research Unit: fasting blood samples; BodPod (body composition), and; whole-body indirect calorimetry. The HG group was treated with TU IM therapy for 6–29 months (mean 14.8-months [SD 8.7]), and assessment at the Human Metabolism Research Unit repeated. T-test comparisons were performed between baseline and follow-up data (HG group), and between baseline data (HG and EG groups). Data reported as mean (SD). Overall, TU IM therapy resulted in a statistically significant improvement in HbA1C (9 mmol/mol, P = 0.03), with 52% improvement in HOMA%B. Improvement in glycaemic control was driven by the HG subgroup with T2D, with 18 mmol/mol [P = 0.02] improvement in HbA1C. Following TU IM therapy, there was a statistically significant reduction in fat mass (3.5 Kg, P = 0.03) and increase in lean body mass (2.9 kg, P = 0.03). Lipid profiles and energy expenditure were unchanged following TU IM therapy. Comparisons between baseline data for HG and EG groups were equivalent apart from differences in Testosterone, SHBG and basal metabolic rate (BMR). In men with obesity-related SH (including a subgroup with T2D), TU IM therapy improved glycaemic control, beta cell function, and body composition.

John Hattersley - One of the best experts on this subject based on the ideXlab platform.

  • metabolic phenotype of male obesity related secondary hypogonadism pre replacement and post replacement therapy with intra muscular Testosterone Undecanoate therapy
    Endocrine, 2018
    Co-Authors: G Dimitriadis, Harpal S Randeva, Saboor Aftab, Asad Ali, John Hattersley
    Abstract:

    To explore the metabolic phenotype of obesity-related secondary hypogonadism (SH) in men pre-replacement and post-replacement therapy with long-acting intramuscular (IM) Testosterone Undecanoate (TU). A prospective observational pilot study on metabolic effects of TU IM in male obesity-related SH (hypogonadal [HG] group, n = 13), including baseline comparisons with controls (eugonadal [EG] group, n = 15). Half the subjects (n = 7 in each group) had type 2 diabetes mellitus (T2D). Baseline metabolic assessment on Human Metabolism Research Unit: fasting blood samples; BodPod (body composition), and; whole-body indirect calorimetry. The HG group was treated with TU IM therapy for 6–29 months (mean 14.8-months [SD 8.7]), and assessment at the Human Metabolism Research Unit repeated. T-test comparisons were performed between baseline and follow-up data (HG group), and between baseline data (HG and EG groups). Data reported as mean (SD). Overall, TU IM therapy resulted in a statistically significant improvement in HbA1C (9 mmol/mol, P = 0.03), with 52% improvement in HOMA%B. Improvement in glycaemic control was driven by the HG subgroup with T2D, with 18 mmol/mol [P = 0.02] improvement in HbA1C. Following TU IM therapy, there was a statistically significant reduction in fat mass (3.5 Kg, P = 0.03) and increase in lean body mass (2.9 kg, P = 0.03). Lipid profiles and energy expenditure were unchanged following TU IM therapy. Comparisons between baseline data for HG and EG groups were equivalent apart from differences in Testosterone, SHBG and basal metabolic rate (BMR). In men with obesity-related SH (including a subgroup with T2D), TU IM therapy improved glycaemic control, beta cell function, and body composition.