Androgen Replacement

Discussion in 'Men's Health Forum' started by Michael Scally MD, Sep 30, 2010.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    testosterone Replacement Therapy for Sexual Symptoms

    Background - Several data have clearly shown that the endocrine system—and androgens in particular—play a pivotal role in regulating all the steps involved in the male sexual response cycle. Accordingly, testosterone (T) replacement therapy (TRT) represents a cornerstone of pharmacologic management of hypogonadal subjects with erectile dysfunction.

    Aim - The aim of this review is to summarize all the available evidence supporting the role of T in the regulation of male sexual function and to provide a comprehensive summary regarding the sexual outcomes of TRT in patients complaining of sexual dysfunction.

    Methods - A comprehensive PubMed literature search was performed.

    Main Outcome Measure - Specific analysis of preclinical and clinical evidence on the role of T in regulating male sexual function was performed. In addition, available evidence supporting the role of TRT on several sexual outcomes was separately investigated.

    Results - T represents an important modulator of male sexual response function. However, the role of T in sexual functioning is less evident in epidemiologic studies because other factors, including organic, relational, and intrapsychic determinants, can orchestrate their effect independently from the state of androgens.

    Nonetheless, it is clear that TRT can ameliorate several aspects of sexual functioning, including libido, erectile function, and overall sexual satisfaction. Conversely, data on the role of TRT in improving orgasmic function are more conflicting. Finally, further controlled studies are needed to investigate the combination of TRT and PDE5 inhibitors.

    Conclusion - Positive effects of TRT are observed only in the presence of a hypogonadal status (ie, total T < 12 nmol/L). In addition, TRT alone can be effective in restoring only milder forms of erectile dysfunction, whereas the combined therapy with other drugs is required when more severe vascular damage is present.

    Rastrelli G, Guaraldi F, Reismann Y, et al. Testosterone Replacement Therapy for Sexual Symptoms. Sex Med Rev 2019.

    Attached Files:

    TheDogSoldier and Millard Baker like this.
  2. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    testosterone and Benign Prostatic Hyperplasia

    Introduction - Benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS) are frequent in aging. Nonetheless, their pathogenesis is largely unknown. The androgen dependence of the first phases of prostate development have inspired the historical view that higher testosterone (T) may be involved in BPH occurrence; however, recent evidence suggests a different scenario.

    Aim - To review the available knowledge on the pathogenesis of BPH particularly concerning the role of T and the possible connections with metabolic impairments.

    Methods - Relevant records were retrieved by an extensive search in Medline, including the following keywords ("testosterone"[MeSH Terms] OR "testosterone"[All Fields]) AND ("prostatic hyperplasia"[MeSH Terms] OR ("prostatic"[All Fields] AND "hyperplasia"[All Fields]) OR "prostatic hyperplasia"[All Fields] OR ("benign"[All Fields] AND "prostatic"[All Fields] AND "hyperplasia"[All Fields]) OR "benign prostatic hyperplasia"[All Fields]). There were no limitations in terms of publication date or study design.

    Main outcome measures - Preclinical and clinical studies have been reported, with special emphasis on our contribution and interpretation.

    Results - Inflammation is a key aspect of BPH development. Along with infectious agents, prostate inflammation can be triggered by metabolic stimuli, such as dyslipidemia, an important component of metabolic syndrome (MetS). Low T and hyperestrogenism frequently occur in MetS. Mounting evidence shows that low, rather than high, T and hyperestrogenism may favor prostate inflammation. Considering these data as a whole, we postulate that BPH is the result of the action of multiple factors, which reinforce their mutual detrimental effects.

    Conclusion - T is not detrimental for the prostate, and treating hypogonadism could even produce relief from LUTS and limit prostatic inflammation, which generates and maintains the process leading to BPH.

    Rastrelli G, Vignozzi L, Corona G, et al. Testosterone and Benign Prostatic Hyperplasia. Sex Med Rev 2019.
    TheDogSoldier and Kinikuman like this.
  3. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    [OA] The Ideal Goal of testosterone Replacement Therapy: Maintaining Testosterone Levels or Managing Symptoms?

    Typically, the goal of testosterone replacement therapy (TRT) is to restore blood testosterone to normal levels. When used to treat men with hypogonadism, it may also result in other benefits including (i) improved sexual desire and erectile function, (ii) improved energy, mood, and vitality, (iii) increased lean body mass, (iv) reduced waist circumference, (v) reduced total body fat mass, (vi) increased bone mineral density, (vii) increased insulin sensitivity, (viii) reduced blood glucose and hemoglobin A1c, and (ix) increased muscle strength as shown in Table 1. Improvement in libido generally occurs within 6 weeks of treatment, whereas other benefits usually take up to 12 months. Thus, the effects of TRT are very diverse. …

    Moon DG, Park HJ. The Ideal Goal of Testosterone Replacement Therapy: Maintaining Testosterone Levels or Managing Symptoms? Journal of clinical medicine 2019;8. The Ideal Goal of Testosterone Replacement Therapy: Maintaining Testosterone Levels or Managing Symptoms?
  4. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Late-onset Hypogonadism and testosterone Therapy - A Summary of Guidelines from the American Urological Association and the European Association of Urology

    Men with low serum testosterone and symptoms of androgen deficiency may be diagnosed with testosterone deficiency. This condition is associated with metabolic syndrome and cardiovascular disease. The benefits (eg, improvement in sexual function) and risks (eg, prostate cancer and cardiovascular disease) of testosterone therapy are controversial.

    The American Urological Association and European Association of Urology guidelines on testosterone therapy differ on several points of management, likely reflecting the ambiguities surrounding testosterone therapy in practice. This paper summarizes both guidelines with a focus on the differences between the two sets of guidelines.

    PATIENT SUMMARY: The benefits and risks of testosterone therapy are controversial, as reflected in the European Association of Urology and American Urological Association guidelines that differ on several points of management.

    Fode M, Salonia A, Minhas S, Burnett AL, Shindel AW. Late-onset Hypogonadism and Testosterone Therapy - A Summary of Guidelines from the American Urological Association and the European Association of Urology. Eur Urol Focus 2019.
  5. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Comparison for Subgroups of Patients with LOH Symptoms Based on Endocrinological Findings - Normal vs Compensated Normal, and Primary Hypogonadism vs Secondary Hypogonadism

    Introduction & Objectives: Regarding men’s health, late-onset hypogonadism (LOH) has gained increased attention in the field of urology and public health in the aging society. The concept of LOH for several symptoms associated with advancing age and a deficiency in serum testosterone levels was suggested by European Association of Urology in 2005.

    Recently, one European study group divided several subgroups of patients with LOH symptoms based on serum luteinizing hormone(LH)and testosterone (T) level to understand their symptoms. In this study, we aimed to identify specific characteristics of the subgroups divided by endocrinological findings in Japanese men with LOH symptoms.

    Materials & Methods: This study comprised 967 male with various LOH symptoms aged >40 (52.6±8.8 y) who visited our hospital or affiliated clinic. Several endocrinological variablesand urological symptoms by specific questionnaires (Sexual Health Inventory for Men ; SHIM, Erection Hardness Score; EHS, International Prostate Symptom Score; IPSS, and the Aging Male Symptoms rating scale; AMS) were assessed.

    Four groups of subject were defined: normal group (NG) (T >3.0 ng/ml and LH <9.4 mIU/l), compensated normal group (CNG) (T >3.0 ng/ml and LH >9.4 mIU/l), primary hypogonadism (PH) (T <3.0 ng/ml and LH <9.4 mIU/l), and secondary hypogonadism (SH) (T <3.0 ng/ml and LH <9.4 mIU/l). We compared NG and CNGand PH and SH to clarify the characteristics of each subgroup.

    Results: The majority of our subjects (83.6%) were classified into NG. Only few patients (3.4%) were classified into CNG. In hypogonadal men, the proportion of SH (12.2%) was much higher than that of PG (0.8%). In a comparison of NG and CNG, age in CNG (64.7 ± 9.0 y) was higher than that in NG (51.9 ± 8.4 y; p < 0.001).

    Regarding symptoms, it was shown that LUTS and sexual function were worse in CNG (11.6±8.4 and 8.4±6.6) than those in NG (14.9±3.1 and 13.5±3.7; p<0.001) by the evaluation of the IPSS (11.6±8.4 vs 14.9±3.1; p<0.001) and sexual subscore of the AMS (8.4±6.6 vs 13.5±3.7; p<0.001).

    In a comparison of PH and SH, age in PH (64.4±12.8 y) was significantly higher than that in SH (52.8±7.8 y; p<0.001). Interestingly, the mental status was worse in SH (12.8±5.1) than that in PH (9.0±3.4; p<0.001) by the evaluation of and mental subscore of the AMS.

    Conclusions: We firstly confirmed that the majority of men with LOH symptoms was classified into NG. We secondly noticed that hypogonadism of aging men was mainly caused by the reduced secretion of LH (SH), not testicular damage (PH).

    Finally, we found there was specific characteristics in each subgroup, even though serum T level was same in the normal range or in the range lower the under limit. In conclusion, classification of LOH into different subgroups by endocrinological variables may help for the diagnosis and management.

    Ishikawa K, Soejima M, Yoshiyama A, et al. 1070 - Comparison for subgroups of patients with LOH symptoms based on endocrinological findings - normal vs compensated normal, and primary hypogonadism vs secondary hypogonadism. European Urology Supplements 2019;18:e1444.
    TheDogSoldier likes this.
  6. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    [OA] Evolution of Guidelines for testosterone Replacement Therapy

    Testosterone is an essential hormone required for the developmental growth and maintenance of the male phenotype during the whole life. With the increasing male life expectancy worldwide and development of adequate testosterone preparations, the prescription of testosterone has increased tremendously. Testosterone replacement should be based on low serum testosterone and related clinical symptoms.

    In the last two decades, with the accumulation of data, official recommendations have evolved in terms of definition, diagnosis, treatment, and follow-up. In practice, it is better for physicians to follow the Institutional Official Recommendations or Clinical Practice Guideline for an adequate diagnosis and treatment of testosterone deficiency. Currently, four official recommendations are available for diagnosis and treatment of patients with testosterone deficiency.

    The inconsistencies in the guidelines merely create confusion among the physicians instead of providing clear information. Furthermore, there is no definite method to assess serum testosterone and clinical symptoms. In the era of active testosterone replacement therapy (TRT), physicians’ practice patterns should be consistent with the clinical practice guidelines to avoid the misuse of testosterone.

    In this review, the author introduces the evolution of clinical guidelines to provide a comprehensive understanding of the differences and controversies with respect to TRT.

    Park JH, Ahn TS, Moon GD. Evolution of Guidelines for Testosterone Replacement Therapy. Journal of clinical medicine 2019;8. Evolution of Guidelines for Testosterone Replacement Therapy
    Millard Baker likes this.
  7. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    [OA] testosterone Replacement Therapy Use Among Active Component Service Men

    This analysis summarizes the prevalence of testosterone replacement therapy (TRT) during 2017 among active component service men by demographic and military characteristics.

    This analysis also determines the percentage of those receiving TRT in 2017 who had an indication for receiving TRT using the 2018 American Urological Association (AUA) clinical practice guidelines.

    In 2017, 5,093 of 1,076,633 active component service men filled a prescription for TRT, for a period prevalence of 4.7 per 1,000 male service members.

    After adjustment for covariates, the prevalence of TRT use remained highest among Army members, senior enlisted members, warrant officers, non-Hispanic whites, American Indians/Alaska Natives, those in combat arms occupations, healthcare workers, those who were married, and those with other/unknown marital status.

    Among active component male service members who received TRT in 2017, only 44.5% met the 2018 AUA clinical practice guidelines for receiving TRT.

    Larsen E, Clausen S, Stahlman S. Testosterone replacement therapy use among active component service men, 2017. Msmr 2019;26:26-31. Medical Surveillance Monthly Report |

    Testosterone Replacement Therapy 201901.png
  8. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Dimitropoulos K, Verze P, Van den Broeck T, et al. What are the benefits and harms of testosterone therapy for male sexual dysfunction?—a systematic review. International journal of impotence research 2019.

    The role of Testosterone Therapy (TTh) in the management of male sexual dysfunction remains unclear. Objective of the authors was to systematically review the relevant literature assessing the benefits and harms of TTh in men with sexual dysfunction. EMBASE, MEDLINE, Cochrane Systematic Reviews—Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane HTA, DARE, HEED), Google Scholar, WHO international Clinical Trials Registry Platform Search Portal, CINAHL databases and were searched systematically in March 2015 and an updated search was performed in March 2016.

    Randomized and non-randomized comparative studies assessing the benefits and harms of TTh in hypogonadal, borderline eugonadal and eugonadal men suffering from sexual dysfunction were included. Risk of bias and confounding assessments were performed. A narrative synthesis was undertaken. Of the 6410 abstracts identified, 36 studies were judged to be eligible for inclusion, including 25 randomized clinical trials (RCTs) and 11 non-randomized comparative studies (NRCSs), recruiting a total of 4944 patients. RCTs were judged to have low or unclear risk of bias, while NRCSs had high risk of bias and thus, overall quality of evidence was judged to be at least unclear.

    Based on the evidence mainly provided by the RCTs included in this systematic review, TTh could be considered for men with low or low-normal testosterone levels and problems with their sexual desire, erectile function and satisfaction derived from intercourse and overall sexual life. The exact testosterone formulation, dosage and duration of treatment remain to be clarified, while the safety profile of TTh also remains unclear. TTh could be used with caution in hypogonadal and most probably borderline eugonadal men to manage disorders of sexual desire, erectile function and sexual satisfaction. The overall low-to-moderate evidence quality highlights the need for robust and adequately designed clinical trials.
    Millard Baker and Old like this.
  9. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Cardiovascular and Cerebrovascular Safety of testosterone Replacement Therapy Among Aging Men with Low Testosterone Levels

    Clinical significance
    · Current use of testosterone replacement therapy among aging men with low testosterone levels was associated with an increased risk of a composite of ischemic stroke, transient ischemic attack, and myocardial infarction.
    · The association was highest in the first two years of use.
    · In aging men, the potential cardiovascular risk of testosterone replacement therapy should be weighed against its expected benefits.

    Purpose - We assessed the risk of ischemic stroke, transient ischemic attack, and myocardial infarction associated with testosterone replacement therapy (TRT) among aging men with low testosterone levels.

    Methods - Using the UK Clinical Practice Research Datalink (CPRD), we formed a cohort of men aged 45 years or older with low testosterone levels and no evidence of hypogonadotropic or testicular disease, between 1995 and 2017. Hazard ratios (HRs) and 95% confidence intervals (CIs) of a composite of ischemic stroke/transient ischemic attack and myocardial infarction were estimated using time-dependent Cox proportional hazards models, comparing current use of TRT with nonuse.

    Results - The cohort included 15,401 men. During 71,541 person-years of follow-up, 850 patients experienced an ischemic stroke/transient ischemic attack /myocardial infarction (crude incidence rate 1.19 (95% CI 1.11–1.27) per 100 persons per year). Compared with nonuse, current use of TRT was associated with an increased risk of the composite outcome (HR 1.21; 95% CI 1.00–1.46). This risk was highest in the first six months to two years of continuous TRT use (HR 1.35; 95% CI 1.01–1.79), as well as among men aged 45–59 years (HR 1.44; 95% CI 1.07–1.92).

    Conclusions - TRT may increase the risk of cardiovascular events in aging men with low testosterone levels, particularly in the first 2 years of use. In the absence of identifiable causes of hypogonadism, TRT should be initiated with caution among aging men with low testosterone levels.

    Loo SY, Azoulay L, Nie R, Dell'Aniello S, Yu OHY, Renoux C. Cardiovascular and cerebrovascular safety of testosterone replacement therapy among aging men with low testosterone levels: a cohort study. The American Journal of Medicine. Redirecting
  10. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    testosterone Replacement in Men with Age-Related Low Testosterone: What Did We Learn From The Testosterone Trials?

    The T Trials were a coordinated set of seven double-blind, placebo-controlled trials to assess efficacy and safety of testosterone versus placebo gel treatment for one year in 788 older men 65 years or older with hypogonadism who had self-reported and objective impairment of sexual and physical function and/or vitality and an average of two morning serum testosterone concentrations < 275 ng/dL. Testosterone dose was adjusted to the mid-normal range for young men.

    Compared to placebo, testosterone treatment moderately improved sexual function, hemoglobin concentration and corrected anemia, and slightly improved walking distance, vitality, mood and depressive symptoms and bone density and strength, but did not improve cognitive function. Testosterone treatment slightly increased non-calcified and total plaque volume; while concerning, the clinical significance of this finding is not clear. Testosterone treatment also increased PSA levels and referral for urological evaluation, and caused erythrocytosis in some men.

    The T Trials provided definitive evidence for short-term clinically meaningful, albeit modest benefits and risks of testosterone treatment in older men with unequivocal age-related hypogonadism. Larger and longer-term placebo-controlled clinical trials are needed to assess the long-term benefits and risks of testosterone treatment on clinical outcomes such as frailty, depression, fractures, prostate cancer and cardiovascular events.

    Matsumoto AM. Testosterone Replacement in Men with Age-Related Low Testosterone: What Did We Learn From The Testosterone Trials? Current Opinion in Endocrine and Metabolic Research 2019.
    TheDogSoldier likes this.
  11. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Kwong JCC, Krakowsky Y, Grober E. testosterone Deficiency: A Review and Comparison of Current Guidelines. J Sex Med 2019.

    Background - There is much controversy regarding the appropriate evaluation and management of testosterone deficiency (TD).

    Aim - To compare current guidelines on the evaluation and management of TD to provide clarity for patients and clinicians, as well as to highlight areas of controversy.

    Methods - A literature search of MEDLINE, Embase, Cochrane Library, and various association websites was performed to identify guidelines for TD.

    Outcomes - Key aspects in the approach were compared, with a focus on the biochemical definition (cutoff) for low testosterone (T), principles of management, and recommendations for testosterone therapy (TTh) in special patient populations.

    Results - Guidelines from the Canadian Medical Association Journal, American Urological Association, European Association of Urology, Endocrine Society, International Society for Sexual Medicine, and British Society for Sexual Medicine were included for review. Recommendations were generally consistent across guidelines.

    Key differences include the biochemical cutoff for low T, and recommendations for patients with low to normal T, prostate cancer, or cardiovascular disease. We highlight several case scenarios in which management differs depending on the guideline adopted.

    Clinical Implications - Although general diagnostic and management principles are in agreement across the guidelines, notable differences may impact patient diagnosis and eligibility for TTh.

    Strengths & Limitations - Only guidelines written in English were included. The quality of the included guidelines was not evaluated, but this was beyond the scope of this review.

    Conclusion - We highlight the limitations of relying exclusively on guidelines in managing patients with TD.
    Millard Baker likes this.
  12. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Clinically Meaningful Change in Sexual Desire in the Psychosexual Daily Questionnaire in Older Men from the TTrials

    Background - A recent study of older men participating in the testosterone Trials (TTrials) defined a clinically meaningful change in the Psychosexual Daily Questionnaire (PDQ) question 4 in hypogonadal men age ≥65 years. This study defines clinically meaningful change in the same population for sexual desire assessed by PDQ question 1.

    Aim - To determine a clinically meaningful change in the answers to question 1 of the PDQ in hypogonadal older men.

    Methods - Participants in the Sexual Function Trial of the TTrials were randomly divided into a training and test set. Anchor-based methods, including regression analysis, receiver operating characteristic curves, and empirical cumulative distribution functions, were used to determine a clinically meaningful change on question 1 in the training set, and the selected threshold was evaluated in the test set for an effect of testosterone treatment.

    Results - A clinically meaningful increase in question 1 of the PDQ was determined to be ≥0.7 points.

    Clinical Implications - Question 1 of the PDQ can be used to assess sexual desire in response to testosterone treatment.

    Strengths & Limitations - Data were obtained from a single large study of older hypogonadal men.

    Conclusion - Clinically meaningful improvement of sexual desire is a change of ≥0.7 in the score of question 1 of the PDQ.

    Stephens-Shields AJ, Wang C, Preston P, Snyder PJ, Swerdloff RS. Clinically Meaningful Change in Sexual Desire in the Psychosexual Daily Questionnaire in Older Men from the TTrials. The journal of sexual medicine.
    Millard Baker likes this.
  13. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    [OA] testosterone Management in Aging Males

    Introduction - Although there is increased public concern about low testosterone levels in aging men, the diagnosis and treatment of hypogonadism in this growing population is controversial.

    Aim - To document the current practices of endocrinologists and urologists in the management of older men with low testosterone in Israel.

    Methods - A 20-question survey of the management of hypogonadism was sent to members of the Israel Endocrine Society and the Israeli Urology Association

    Main Outcome Measures - Participants were interviewed about their practice in diagnostic workup, prescription habits and monitoring of testosterone therapy.

    Results - The response rate was low (range 8–12%). Significant differences were found between members of the 2 professional associations. Overall, endocrinologists take a more conservative approach to the diagnosis and initial workup, modes of treatment, and to concerns about the safety of testosterone therapy. A divergence from the published clinical guidelines was also noted in some aspects of the clinical practices in both groups.

    Clinical Implications - Significant variances in the diagnosis and treatment approach of hypogonadism between endocrinologists and urologists, as well as divergences from clinical guidelines, may lead to misuse of testosterone therapy.

    Strengths & Limitations - This is the first study undertaken in Israel among urologists and endocrinologists of this increasingly recognized health issue. In our country, these 2 groups of physicians comprise nearly all of the testosterone treatment providers. The limitation of this study is linked to bias of all surveys based on subjective reporting, the fact that it was performed in only 1 country, and that we did not control for the specific assay used to measure testosterone levels.

    Conclusions - These findings highlight the need for the implementation of coordinated guidelines to facilitate the appropriate diagnosis and treatment of men who can benefit from testosterone therapy and to minimize the risks of this therapy.

    Ishay A, Tzemah S, Nitzan R, et al. Testosterone Management in Aging Males: Surveying Clinical Practices of Urologists and Endocrinologists in Israel. Sex Med 2019.
    Kinikuman, Dr JIM and Millard Baker like this.
  14. Dr JIM

    Dr JIM Member

    Yep and contrary to TRT forum hype
    there’s much more to the DX of hypogonadism than some arbitrary level.

    Kinikuman likes this.
  15. Goingstronger

    Goingstronger Member

    This channel is interesting:

    Weight Lifting Dermatologist

    This guy gathered a few endos to discuss TRT topics, among which Dr Keith Nichols.
    They are big proponents of scrotum transdermal applications for stable T levels and rocket high DHT levels.

    Their main position is that: given the amount of xenoestrogens in litteraly everything today, most men's androgen receptors are saturated and can't receive androgens properly.
    So even if you have T levels in the 800s today, you are most likely only receiving the equivalent androgenic activity of someone who was in the 200s back in the 1950s.

    Their conclusion: don't go by number, but by feel. If it takes 300mg of test per week to feel good and TT levels in the 2000s, then that's what it takes and should be on this year round.

    @Michael Scally MD @Dr JIM does that theory hold any water?
    TheDogSoldier likes this.
  16. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Guideline of Guidelines: testosterone Replacement Therapy for Testosterone Deficiency

    Only men meeting the criteria for testosterone deficiency (TD) should be treated.

    Consider screening asymptomatic men with certain conditions that increase the risk of TD.

    Exogenous testosterone therapy causes impairment of spermatogenesis.


    Men on testosterone therapy require careful monitoring of labs.

    Salter CA, Mulhall JP. Guideline of Guidelines: Testosterone Replacement Therapy for Testosterone Deficiency. BJU international 2019. Error - Cookies Turned Off
    Kinikuman and Millard Baker like this.
  17. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    testosterone for Androgen Deficiency-Like Symptoms in Men Without Pathologic Hypogonadism

    BACKGROUND: Off-label testosterone prescribing for androgen deficiency (AD)-like sexual and energy symptoms of older men without pathologic hypogonadism has increased dramatically without convincing evidence of efficacy.

    METHODS: In a randomized, double-blind, placebo-controlled study with three phases we entered 45 men aged at least 40 years without pathologic hypogonadism but with AD-like energy and/or sexual symptoms to either daily testosterone or placebo gel treatment for 6 weeks in a cross-over study design with a third, mandatory extension phase in which participants chose which previous treatment they preferred to repeat while remaining masked to their original treatment. Primary endpoints were energy and sexual symptoms as assessed by a visual analog scale (Lead Symptom Score (LSS)).

    RESULTS: Increasing serum testosterone to the healthy young male range produced no significant benefit more than placebo for energy or sexual LSS. Covariate effects of age, BMI and pre-treatment baseline serum testosterone on quality of life scales were detected. Only 1 out of 22 indices from 7 quality of life scales was significantly improved by testosterone treatment over placebo. Participants did not choose testosterone significantly more than placebo as their preferred treatment in the third phase.

    CONCLUSIONS: 6 weeks testosterone treatment does not improve energy or sexual symptoms more than placebo in symptomatic men without pathologic hypogonadism.

    Mok SF, Fennell C, Savkovic S, et al. Testosterone for Androgen Deficiency-Like Symptoms in Men Without Pathologic Hypogonadism: A Randomized, Placebo-Controlled Cross-Over with Masked Choice Extension Clinical Trial. The journals of gerontology Series A, Biological sciences and medical sciences 2019. Testosterone for Androgen Deficiency-Like Symptoms in Men Without Pathologic Hypogonadism: A Randomized, Placebo-Controlled Cross-Over with Masked Choice Extension Clinical Trial
    TheDogSoldier likes this.
  18. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Efficacy of Combined Treatment of Intramuscular testosterone Injection and Testosterone Ointment Application

    Introduction: The best method for administering testosterone replacement therapy (TRT) for late-onset hypogonadism (LOH) remains controversial. This study aimed to compare the efficacy and safety of a combined treatment (CT) involving intramuscular testosterone injection and testosterone ointment application [Glowmin((R)) (GL)] with intramuscular injection monotherapy (IMIM).

    Materials and methods: Patients were randomly assigned as follows:
    · Group 1 received IMIM for 12 weeks and CT for 12 weeks and
    · Group 2 received CT for 12 weeks and IMIM for 12 weeks.

    Patients were then asked about their treatment preferences:
    (A) IMIM,
    (B) a combination of IMIM and ointment, or
    (C) either A or B. Results:

    Patients (n = 43) completed the study without any adverse effects. No significant differences between each treatment period were found.

    In Group 1, most patients chose B (n = 13) while in Group 2, most chose A (n = 10). In each group, patients preferred the second treatment phase; however, statistical significance was not reached between A and B (Group 1, p = 0.11 and Group 2, p = 0.47, respectively).

    Conclusion: TRT by CT is compatible with TRT by IMIM. Patients who cannot continue TRT because of polycythemia from IMIM may be suited to CT.

    Narukawa T, Soh J, Kanemitsu N, Harikai S, Ukimura O. Efficacy of combined treatment of intramuscular testosterone injection and testosterone ointment application for late-onset hypogonadism: an open-labeled, randomized, crossover study. The aging male : the official journal of the International Society for the Study of the Aging Male 2019:1-7.
  19. Goingstronger

    Goingstronger Member

    Why would IM lead to polycythemia to a higher degree than transdermal?
  20. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Higher nadir/peak values. This study was crap.
    Goingstronger likes this.