Endocrine aspects of male sexual dysfunctions. A double-blind, placebo-controlled trial of testosterone therapy for HIV-positive men with hypogonadal symptoms. Effects of androgen on sexual behavior in hypogonadal men. Effects of a supraphysiological dose of testosterone on physical function, muscle performance, mood, and fatigue in men with HIV-associated weight loss. Testosterone dose-response relationships in healthy young men. 12-Month Observation of Testosterone Replacement Effectiveness in a General Population of Men Effect of oral testosterone undecanoate on visuospatial cognition, mood and quality of life in elderly men with low-normal gonadal status. Transdermal testosterone therapy improves well-being, mood, and sexual function in premenopausal women Testosterone influences spatial cognition in older men. The effects of exogenous testosterone on sexuality and mood of normal men. Effect of Testosterone Administration on Sexual Behavior and Mood in Men with Erectile Dysfunction Effects of Testosterone Administration for 3 Years on Subclinical Atherosclerosis Progression in Older Men With Low or Low-Normal Testosterone Levels: A Randomized Clinical Trial. Clomiphene citrate effects on testosterone/estrogen ratio in male hypogonadism. A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder Testosterone therapy increases sexual desire in ageing men with low–normal testosterone levels and symptoms of androgen deficiency Testosterone dose-response relationships in hysterectomized women with or without oophorectomy: effects on sexual function, body composition, muscle performance and physical function in a randomized trial Effect of testosterone supplementation with and without a dual 5α-reductase inhibitor on fat-free mass in men with suppressed testosterone production: a randomized controlled trial. Effects of testosterone and progressive resistance training in eugonadal men with AIDS wasting. A randomized, controlled trial. Testosterone therapy for human immunodeficiency virus-positive men with and without hypogonadism. Effects of testosterone and resistance training in men with chronic obstructive pulmonary disease. Effects of transdermal testosterone on cognitive function and health perception in older men with low bioavailable testosterone levels. Testosterone Treatment of Men With Mild Cognitive Impairment and Low Testosterone Levels PERCEIVED EFFECTS OF TESTOSTERONE REPLACEMENT THERAPY IN PERIMENOPAUSAL AND POSTMENOPAUSAL WOMEN: AN INTERNET PILOT STUDY
INTRODUCTION Endocrine disorders may adversely affect men 's sexual function . AIM To provide recommendations based on best evidence for diagnosis and treatment of endocrine-related male sexual dysfunctions .  METHODS The Endocrine Aspects of Male Sexual Dysfunctions Committee , including 11 members from eight countries and four continents , collaborated with the Endocrine subcommittee of the St and ards Committee of the International Society for Sexual Medicine . Medical literature was review ed in detail , followed by extensive internal committee discussion over 2 years , then public presentation and discussion with the other experts before finalizing the report . MAIN OUTCOME MEASURE Recommendations based on grading of evidence -base medical literature and interactive discussion . RESULTS From animal studies , it is derived that testosterone modulates mechanisms involved in erectile machinery , including expression of enzymes that both initiate and terminate erection . In addition , testosterone is essential for sexual motivation . Whether these findings could be extrapolated to human erections is unclear . Testosterone plays a broad role in men 's overall health . Recent studies have established strong associations between low testosterone and metabolic and cardiovascular imbalances . In some studies , low testosterone decreased longevity ; however , longitudinal studies do not support the predictive value of low testosterone for further cardiovascular events . The article proposes a st and ardized process for diagnosis and treatment of endocrine-related male sexual dysfunctions , updating the knowledge on testosterone and prostate safety . There is no compelling evidence that testosterone treatment causes prostate cancer or its progression in men without severe testosterone deficiency ( TD ) . The possible roles of prolactin and thyroid hormones are also examined . CONCLUSIONS Men with erectile dysfunction , hypoactive sexual desire and retarded ejaculation  , as well as those with visceral obesity and metabolic diseases , should be screened for TD and treated . Prospect i ve interventional studies are required before screening for TD in more conditions , including cardiovascular diseases , and considering correction as preventive medicine as much data suggests BACKGROUND The goal was to evaluate the efficacy of testosterone in alleviation of hypogonadal symptoms ( diminished libido , depressed mood , low energy , and depleted muscle mass ) in men with symptomatic human immunodeficiency virus illness . METHODS Seventy-four patients were enrolled in a double-blind , placebo-controlled 6-week trial with bi-weekly testosterone injections , followed by 12 weeks of open-label maintenance treatment . Major outcome measures were Clinical Global Impressions Scale ratings for libido , mood , energy , and erectile function ; Hamilton Depression Rating Scale scores , and Chalder Fatigue Scale scores . Body composition changes were assessed with bioelectric impedance analysis . RESULTS Seventy men completed the 6-week trial . Response rates , defined as much or very much improved libido , were 74 % ( 28/38 ) for patients r and omized to testosterone , and 19 % ( 6/32 ) for placebo-treated patients ( P<.001 ) . Of the 62 completers with fatigue at baseline , 59 % ( 20/34 ) receiving testosterone and 25 % ( 7/28 ) receiving placebo reported improved energy ( P<.01 ) . Among the 26 completers with an Axis I depressive disorder at baseline , 58 % of the testosterone-treated patients reported improved mood compared with 14 % of placebo-treated patients ( Fisher exact test = .08 ) . With testosterone treatment , average increase in muscle mass over 12 weeks was 1.6 kg for the whole group , and 2.2 kg for the 14 men with wasting at baseline . Improvement on all parameters was maintained during subsequent open-label treatment for up to 18 weeks . CONCLUSION Testosterone is well tolerated and effective in the short-term treatment of symptoms of clinical hypogonadism in men with symptomatic human immunodeficiency virus illness , restoring libido and energy , alleviating depressed mood , and increasing muscle mass Despite the widespread use of and rogen in the treatment of hypogonadal men , its efficacy in restoring sexual behavior to hypogonadal patients has not been established in appropriately controlled behavioral studies . Accordingly , testosterone enanthate or vehicle was injected once every 4 weeks i m in a double blind experiment . The subjects were six adult males , aged 32 - 65 yr , two with gonadal failure and four with secondary hypogonadism . Two doses of testosterone ( 100 and 400 mg ) were administered for approximately 5 months , with the treatments varied at r and om within and among subjects . Details of sexual activity and experience were followed by the use of daily logs . Frequencies of erections , including nocturnal erections and coitus , showed significant dose-related responses to and rogen treatment which closely followed the fluctuations in the circulating testosterone level . As indicated by the Profile of Mood States test , behavioral responses did not appear to be mediated by changes in mood . We concluded that the stimulatory effects of testosterone on sexual activity are rapid , reliable , and not due to a placebo effect . To maintain plasma testosterone and adequate sexual function within normal levels , even high doses of testosterone enanthate should be given no less frequency than once every 3 weeks Testosterone increases fat-free mass ( FFM ) in men infected with human immunodeficiency virus ( HIV ) , but its effects on muscle performance , physical function , mood , and quality of life are poorly understood . Sixty-one HIV-infected men with weight loss were r and omized to receive weekly intramuscular injections of 300 mg of testosterone enanthate or placebo for 16 wk . The primary outcome of interest was physical function ( walking speed , stair-climbing power , and load-carrying ability ) . Secondary outcome measures included body weight and composition , muscle performance , sexual function , mood , and quality of life . Serum nadir free and total testosterone levels increased ( + 188.0 + /- 29.6 and + 720 + /- 86 ng/dl ) in the testosterone , but not placebo , group . Testosterone administration was associated with increased FFM ( 2.8 + /- 0.5 kg ) , which was significantly greater than in the placebo group ( P < 0.0001 ) . Leg press strength increased significantly in testosterone-treated ( P = 0.027 ) , but not placebo-treated , men ; the difference between groups was not significant . Other measures of muscle performance and physical function did not change significantly in either group . Men receiving testosterone demonstrated significantly greater improvements in mental health and quality -of-life scores than those receiving placebo and improvements in fatigue/energy and mood scores that were not significantly different from those receiving placebo .  Sexual function scores did not change in either group . In HIV-infected men with weight loss , a supraphysiological dose of testosterone significantly increased FFM but did not improve self-reported or performance-based measures of physical function . Improvements in mood , fatigue , and quality -of-life measures in the testosterone group , although clinical ly important , need further confirmation Testosterone increases muscle mass and strength and regulates other physiological processes , but we do not know whether testosterone effects are dose dependent and whether dose requirements for maintaining various and rogen-dependent processes are similar . To determine the effects of grade d doses of testosterone on body composition , muscle size , strength , power , sexual and cognitive functions , prostate-specific antigen ( PSA ) , plasma lipids , hemoglobin , and insulin-like growth factor I ( IGF-I ) levels , 61 eugonadal men , 18 - 35 yr , were r and omized to one of five groups to receive monthly injections of a long-acting gonadotropin-releasing hormone ( GnRH ) agonist , to suppress endogenous testosterone secretion , and weekly injections of 25 , 50 , 125 , 300 , or 600 mg of testosterone enanthate for 20 wk . Energy and protein intakes were st and ardized . The administration of the GnRH agonist plus grade d doses of testosterone result ed in mean nadir testosterone concentrations of 253 , 306 , 542 , 1,345 , and 2,370 ng/dl at the 25- , 50- , 125- , 300- , and 600-mg doses , respectively . Fat-free mass increased dose dependently in men receiving 125 , 300 , or 600 mg of testosterone weekly ( change + 3.4 , 5.2 , and 7.9 kg , respectively ) . The changes in fat-free mass were highly dependent on testosterone dose ( P = 0.0001 ) and correlated with log testosterone concentrations ( r = 0.73 , P = 0.0001 ) . Changes in leg press strength , leg power , thigh and quadriceps muscle volumes , hemoglobin , and IGF-I were positively correlated with testosterone concentrations , whereas changes in fat mass and plasma high-density lipoprotein ( HDL ) cholesterol were negatively correlated . Sexual function , visual-spatial cognition and mood , and PSA levels did not change significantly at any dose . We conclude that changes in circulating testosterone concentrations , induced by GnRH agonist and testosterone administration , are associated with testosterone dose- and concentration-dependent changes in fat-free mass , muscle size , strength and power , fat mass , hemoglobin , HDL cholesterol , and IGF-I levels , in conformity with a single linear dose-response relationship . However , different and rogen-dependent processes have different testosterone dose-response relationships Abstract Background : Testosterone decline becomes more prevalent as men age and symptomatic testosterone deficiency is associated with potentially serious comorbidities . Despite limitations , registries can provide an opportunity to accumulate data regarding disease management in a typical patient population , including diagnosis , treatment , and outcomes . Material s and Methods : The Testim Registry in the United States ( TRiUS ) was a prospect i ve , 12-month , observational cohort registry of men prescribed Testim ® ( 1 % testosterone gel ; Auxilium Pharmaceuticals , Inc. ) for the first time ; patients previously on other forms of testosterone replacement therapy ( TRT )  were eligible to participate in the study as well . The registry recorded total testosterone ( TT ) and free testosterone ( FT ) levels , prostate-specific antigen ( PSA ) , sexual function , mood/depression , and cardiometabolic and anthropometric criteria before and after TRT . Changes over time were analyzed by analysis of variance , and linear regression and Pearson product-moment correlation coefficients were used to examine relationships between variables . Results : At baseline , 849 patients from 72 sites were enrolled , with 743 of 849 started on 5 g gel/day ( 50 mg testosterone/day ) and 106 of 849 started on 10 g gel/day ( 100 mg testosterone/day ) . Mean TT and FT levels increased significantly after 3 months of TRT ( TT level , 16.8 ± 9.87 nmol/L [ 485 ± 284 ng/dL ] , P < 0.001 ; FT level , 286.3 ± 224.9 pmol/L [ 82.5 ± 64.8 pg/mL ] , P < 0.001 ) and were maintained at eugonadal levels . Mean PSA levels increased significantly ( P = 0.004 ) from 1.12 ± 1.11 μg/L ( 1.12 + 1.11 ng/mL ) at baseline to 1.26 ± 1.22 μg/L ( 1.26 ± 1.22 ng/mL ) after 12 months of TRT , although changes were well within guidelines ( < 1.4 μg/L/year increase ) . Significant improvements were seen in sexual function and mood/depression at 3 months and in metabolic parameters at 12 months . Conclusion : Testosterone deficiency symptoms improved with TRT use in men ; sexual function and mood/depression improvements were seen before metabolic improvements . Prostate-specific antigen levels increased , although increases were within guideline -determined safety limits OBJECTIVES The effects of supplemental testosterone on cognition , mood and wellbeing in ageing men are unclear . This study aim ed to assess the effect of 12-months of oral testosterone supplementation on cognitive function , mood and quality of life in elderly men with low-normal gonadal status , not specifically selected for cognitive or mood defects . METHODS A st and ard oral dose ( 80 mg twice daily ) of testosterone undecanoate ( TU ) or placebo was administered for one year to 76 healthy men 60 years or older . All men had a free testosterone index ( FTI ) of 0.3 - 0.5 , which represents a value below the normal lower limit for young men ( 19 - 30 years ) , but remains within the overall normal male range . A neuropsychological assessment including the trail making test ( part B ) , visuospatial ( VSP ) block design test , mini mental state exam ( MMSE ) , Geriatric Depression Scale ( GDS ) , a 5-point Likert and a 10-point visual analogue quality of life ( QoL ) scale , along with serum hormone measurements were obtained at baseline , 6 , and 12 months . RESULTS Although calculated bioavailable testosterone ( cBT ) and FTI were higher , and muscle mass increased after 12 months , there was no difference in scores on the trail making or VSP block tests , the MMSE , GDS or either of the QoL scales between the testosterone and placebo group . There was no relationship between baseline cBT or FTI and treatment effect for any of the outcome measures . CONCLUSIONS 12-month supplementation with oral TU does not affect scores on visuospatial tests or mood and quality of life scales in older men with low-normal gonadal status Objective Circulating testosterone in women declines during the late reproductive years such that otherwise healthy women in their 40s have approximately half the testosterone level as women in their 20s . Despite this , research showing the benefits of and rogen replacement has been limited to the postmenopausal years . In view of the known premenopausal physiological decline in testosterone , we have evaluated the efficacy of transdermal testosterone therapy on mood , well-being , and sexual function in eugonadal , premenopausal women presenting with low libido . Design Premenopausal women with low libido participated in a r and omized , placebo-controlled , crossover , efficacy study of testosterone cream ( 10 mg/day ) with two double-blind , 12-week , treatment periods separated by a single-blind , 4-week , washout period . Results Thirty-four women completed the study per protocol , with 31 women ( mean age 39.7 ± 4.2 years ; serum testosterone 1.07 + 0.50 nmol/L ) providing complete data  . Testosterone therapy result ed in statistically significant improvements in the composite scores of the Psychological General Well-Being Index [ + 12.9 ( 95 % CI , + 4.6 to + 21.2 ) , P = 0.003 ] and the Sabbatsberg Sexual Self-Rating Scale [ + 15.7 ( 95 % CI , + 6.5 to + 25.0 ) , P = 0.001 ] compared with placebo . A mean decrease in the Beck Depression Inventory score approached significance [ −2.8 ( 95 % CI , −5.7 to + 0.1 ) , P = 0.06 ] . Mean total testosterone levels during treatment were at the high end of the normal range , and estradiol was unchanged . No adverse effects were reported . Conclusions Testosterone therapy  improves well-being , mood , and sexual function in premenopausal women with low libido and low testosterone . As a substantial number of women experience diminished sexual interest and well-being during their late reproductive years , further research is warranted to evaluate the benefits and safety of longer-term intervention Testosterone plays a role in the organization of behavior during development . The authors examined whether testosterone could play a maintenance role in behavior as well . In a double-blind manner , verbal and visual memory , spatial cognition , motor speed , cognitive flexibility , and mood in a group of healthy older men who were supplemented for 3 months with testosterone  were assessed . The increase in testosterone levels to 150 % of baseline levels result ed in a significant enhancement of spatial cognition , but no change in any other cognitive domain was found . Testosterone supplementation influenced the endogenous production of estradiol , and estradiol was found to have an inverse relationship to spatial cognitive performance . These results suggest that testosterone supplementation can modify spatial cognition in older men ; however , it is likely that this occurs through testosterone 's influence on estrogen The effects of supraphysiological levels of testosterone , used for male contraception , on sexual behavior and mood were studied in a single-blind , placebo-controlled manner in a group of 31 normal men . After 4 weeks of baseline observations , the men were r and omized into two groups : one group received 200 mg testosterone enanthate ( TE ) weekly by i m injection for 8 weeks ( Testosterone Only group ) , the other received placebo injections once weekly for the first 4 weeks followed by TE 200 mg weekly for the following 4 weeks ( Placebo/Testosterone group ) . The testosterone administration increased trough plasma testosterone levels by 80 % , compatible with peak testosterone levels 400 - 500 % above baseline . Various aspects of sexuality were assessed using sexuality experience scales ( SES ) question naires at the end of each 4-week period while sexual activity and mood states were recorded by daily dairies and self-rating scales . In both groups there was a significant increase in scores in the Psychosexual Stimulation Scale of the SES ( i.e. SES 2 ) following testosterone administration , but not with placebo . There were no changes in SES 3 , which measures aspects of sexual interaction with the partner . In both groups there were no changes in frequency of sexual intercourse , masturbation , or penile erection on waking nor in any of the moods reported . The Placebo/Testosterone group showed an increase in self-reported interest in sex during testosterone treatment but not with placebo . The SES 2 results suggest that sexual awareness and arousability can be increased by supraphysiological levels of testosterone . However , these changes are not reflected in modifications of overt sexual behavior , which in eugonadal men may be more determined by sexual relationship factors . This contrasts with hypogonadal men , in whom testosterone replacement clearly stimulates sexual behavior . There was no evidence to suggest an alteration in any of the mood states studied , in particular those associated with increased aggression . We conclude that supraphysiological levels of testosterone maintained for up to 2 months can promote some aspects of sexual arousability without stimulating sexual activity in eugonadal men within stable heterosexual relationships . Raising testosterone does not increase self-reported ratings of aggressive feelings This double-blind placebo controlled , cross-over study was carried out to assess the effect of testosterone administration on sexual behavior mood , and psychological symptoms in healthy men with erectile dysfunction . Biweekly injections of 200 mg of testosterone enanthate were given over a period of 6 weeks separated by a washout period of 4 weeks . Blood sample s for hormonal assessment , behavioral and psychological ratings were obtained prior to each injection . Luteinizing hormone remained significantly depressed but circulating testosterone had returned to baseline levels by 2 weeks following each hormonal injection . The ejaculatory frequency during the testosterone phase was statistically higher than during the placebo phase . There were marked , although statistically nonsignificant , increases in median frequency of reported sexual desire , masturbation , sexual experiences with partner , and sleep erections during the testosterone period . Testosterone did not have demonstrable effects on ratings of penile rigidity and sexual satisfaction . Mood variables and psychological symptoms did not change following hormonal administration . Results suggest that and rogen administration to eugonadal men with erectile dysfunction may activate their sexual behavior without enhancing erectile capacity and without effects on mood and psychological symptoms IMPORTANCE Testosterone use in older men is increasing , but its long-term effects on progression of atherosclerosis are unknown . OBJECTIVE To determine the effect of testosterone administration on sub clinical atherosclerosis progression in older men with low or low-normal testosterone levels . DESIGN , SETTING , AND PARTICIPANTS Testosterone 's Effects on Atherosclerosis Progression in Aging Men ( TEAAM ) was a placebo-controlled , double-blind , parallel-group r and omized trial involving 308 men 60 years or older with low or low-normal testosterone levels ( 100 - 400 ng/dL ; free testosterone < 50 pg/mL ) , recruited at 3 US centers . Recruitment took place between September 2004 and February 2009 ; the last participant completed the study in May 2012 . INTERVENTIONS One hundred fifty-six participants were r and omized to receive 7.5 g of 1 % testosterone and 152 were r and omized  to receive placebo gel packets daily for 3 years . The dose was adjusted to achieve testosterone levels between 500 and 900 ng/dL. MAIN OUTCOMES AND MEASURES Co primary outcomes included common carotid artery intima-media thickness and coronary artery calcium ; secondary outcomes included sexual function and health-related quality of life . RESULTS Baseline characteristics were similar between groups : patients were a mean age of 67.6 years ; 42 % had hypertension ; 15 % , diabetes ; 15 % , cardiovascular disease ; and 27 % , obesity . The rate of change in intima-media thickness was 0.010 mm/year in the placebo group and 0.012 mm/year in the testosterone group ( mean difference adjusted for age and trial site , 0.0002 mm/year ; 95 % CI , -0.003 to 0.003 , P = .89 ) . The rate of change in the coronary artery calcium score was 41.4 Agatston units/year in the placebo group and 31.4 Agatston units/year in the testosterone group ( adjusted mean difference , -10.8 Agatston units/year ; 95 % CI , -45.7 to 24.2 ; P = .54 ) . Changes in intima-media thickness or calcium scores were not associated with change in testosterone levels among individuals assigned to receive testosterone . Sexual desire , erectile function , overall sexual function scores , partner intimacy , and health-related quality of life did not differ significantly between groups . Hematocrit and prostate-specific antigen levels increased more in testosterone group . CONCLUSIONS AND RELEVANCE Among older men with low or low-normal testosterone levels , testosterone administration for 3 years vs placebo did not result in a significant difference in the rates of change in either common carotid artery intima-media thickness or coronary artery calcium nor did it improve overall sexual function or health-related quality of life . Because this trial was only powered to evaluate atherosclerosis progression , these findings should not be interpreted as establishing cardiovascular safety of testosterone use in older men . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00287586 AIM Symptomatic late-onset hypogonadism is associated not only with a decline in serum testosterone , but also with a rise in serum estradiol . These endocrine changes negatively affect libido , sexual function , mood , behavior , lean body mass , and bone density . Currently , the most common treatment is exogenous testosterone therapy . This treatment can be associated with skin irritation , gynecomastia , nipple tenderness , testicular atrophy , and decline in sperm counts . In this study we investigated the efficacy of clomiphene citrate in the treatment of hypogonadism with the objectives of raising endogenous serum testosterone ( T ) and improving the testosterone/estrogen ( T/E ) ratio . METHODS Our cohort consisted of 36 Caucasian men with hypogonadism defined as serum testosterone level less than 300 ng/dL. Each patient was treated with a daily dose of 25 mg clomiphene citrate and followed prospect ively . Analysis of baseline and follow-up serum levels of testosterone and estradiol levels were performed . RESULTS The mean age was 39 years , and the mean pretreatment testosterone and estrogen levels were 247.6 + /- 39.8 ng/dL and 32.3 + /- 10.9 , respectively . By the first follow-up visit ( 4 - 6 weeks ) , the mean testosterone level rose to 610.0 + /- 178.6 ng/dL ( P < 0.00001 ) . Moreover , the T/E ratio improved from 8.7 to 14.2 ( P < 0.001 ) . There were no side effects reported by the patients . CONCLUSIONS Low dose clomiphene citrate is effective in elevating serum testosterone levels and improving the testosterone/estradiol ratio in men with hypogonadism . This therapy represents an alternative to testosterone therapy by stimulating the endogenous and rogen production pathway Objectives To assess the safety and efficacy of 10 mg topical testosterone therapy daily ( 2 cm And ro-Feme ® cream ) as a treatment for low sexual desire in postmenopausal hysterectomized women who were already on transdermal estrogen . Methods A double-blind , r and omized , placebo-controlled , cross-over study ( each period being of 3 months ' duration ) was performed in the research center of a tertiary referral women 's hospital . Thirty-six menopausal healthy women were recruited who had undergone a hysterectomy , who were not depressed , were in a stable relationship and who fulfilled diagnostic criteria for low sexual desire , as measured by the Brief Index of Sexual Function for Women ( BISF-W ) . Main outcome measures The primary outcome measure was improvement in the sexuality score as measured by a vali date d tool ( BISF-W ) ; secondary measures were sub-scores of the BISF-W , effect on mood and energy , lipids and testosterone levels .  Results Testosterone cream significantly improved sexual desire , frequency of sex , receptivity and initiation as measured by the BISF-W score . It did not change mood , energy , lipids , blood pressure or weight over the study period . Conclusions Testosterone cream significantly improved sexual scores in menopausal women with low sexual desire . It was effective , easy to use and had no side-effects over the 3-month period of active treatment . It offers a novel and acceptable method of administering testosterone to menopausal women Although decline in sexual function is a common reason for ageing men to seek advice regarding testosterone therapy , placebo-controlled trial data have been unable to show a consistent , beneficial role for testosterone . The objective of this study was to determine the effect of testosterone therapy on sexual function in non-obese ageing men with symptoms of and rogen deficiency and low – normal serum testosterone levels . A total of 60 men aged 55 years or older in good general health with total testosterone ( TT ) levels < 15 nM , and with symptoms suggestive of and rogen deficiency , were r and omized in a double-blinded protocol to transdermal testosterone patches or placebo for 12 months  . Sexual function was assessed using the International Index of Erectile Function at weeks 0 , 26 and 52 . In men receiving testosterone TT levels increased by 30 % ( P=0.01 ) and luteinizing hormone decreased by 50 % ( P<0.001 ) . Relative to placebo , testosterone therapy improved sexual desire ( P=0.04 ) ; however other parameters of sexual function including erectile function were unaffected by the treatment . Ageing men in good general health and with symptoms of and rogen deficiency and low – normal serum testosterone levels receiving 12 months of transdermal testosterone therapy experienced , relative to placebo , improved sexual desire but no effect on other parameters of sexual function Objective This study aims to determine the dose-dependent effects of testosterone on sexual function , body composition , muscle performance , and physical function in hysterectomized women with or without oophorectomy . Methods Seventy-one postmenopausal women who previously underwent hysterectomy with or without oophorectomy and had total testosterone levels less than 31 ng/dL or free testosterone levels less than 3.5 pg/mL received a st and ardized transdermal estradiol regimen during the 12-week run-in period and were r and omized to receive weekly intramuscular injections of placebo or 3 , 6.25 , 12.5 , or 25 mg of testosterone enanthate for 24 weeks .  Total and free testosterone levels were measured by liquid chromatography – t and em mass spectrometry and equilibrium dialysis , respectively . The primary outcome was change in sexual function measured by the Brief Index of Sexual Functioning for Women . Secondary outcomes included changes in sexual activity , sexual distress , Derogatis Interview for Sexual Functioning , lean body mass , fat mass , muscle strength and power , and physical function .  Results Seventy-one women were r and omized ; five groups were similar at baseline . Sixty-two women with analyzable data for the primary outcome were included in the final analysis . The mean on-treatment total testosterone concentrations were 19 , 78 , 102 , 128 , and 210 ng/dL in the placebo , 3-mg , 6.25-mg , 12.5-mg , and 25-mg groups , respectively . Changes in composite Brief Index of Sexual Functioning for Women scores , thoughts/desire , arousal , frequency of sexual activity , lean body mass , chest-press power , and loaded stair-climb power were significantly related to increases in free testosterone concentrations ; compared with placebo , changes were significantly greater in women assigned to the 25-mg group , but not in women in the lower-dose groups . Sexual activity increased by 2.7 encounters per week in the 25-mg group . The frequency of and rogenic adverse events was low . Conclusions Testosterone administration in hysterectomized women with or without oophorectomy for 24 weeks was associated with dose and concentration-dependent gains in several domains of sexual function , lean body mass , chest-press power , and loaded stair-climb power . Long-term trials are needed to weigh improvements in these outcomes against potential long-term adverse effects CONTEXT Steroid 5α-reductase inhibitors are used to treat benign prostatic hyperplasia and and rogenic alopecia , but the role of 5α-dihydrotestosterone ( DHT ) in mediating testosterone 's effects on muscle , sexual function , erythropoiesis , and other and rogen-dependent processes remains poorly understood . OBJECTIVE To determine whether testosterone 's effects on muscle mass , strength , sexual function , hematocrit level , prostate volume , sebum production , and lipid levels are attenuated when its conversion to DHT is blocked by dutasteride ( an inhibitor of 5α-reductase type 1 and 2 ) . DESIGN , SETTING , AND PATIENTS The 5α-Reductase Trial was a r and omized controlled trial of healthy men aged 18 to 50 years comparing placebo plus testosterone enthanate with dutasteride plus testosterone enanthate from May 2005 through June 2010 . INTERVENTIONS Eight treatment groups received 50 , 125 , 300 , or 600 mg/wk of testosterone enanthate for 20 weeks plus placebo ( 4 groups ) or 2.5 mg/d of dutasteride ( 4 groups ) . MAIN OUTCOME MEASURES The primary outcome was change in fat-free mass ; secondary outcomes : changes in fat mass , muscle strength , sexual function , prostate volume , sebum production , and hematocrit and lipid levels . RESULTS A total of 139 men were r and omized ; 102 completed the 20-week intervention . Men assigned to dutasteride were similar at baseline to those assigned to placebo . The mean fat-free mass gained by the dutasteride groups was 0.6 kg ( 95 % CI , -0.1 to 1.2 kg ) when receiving 50 mg/wk of testosterone enanthate , 2.6 kg ( 95 % CI , 0.9 to 4.3 kg ) for 125 mg/wk , 5.8 kg ( 95 % CI , 4.8 to 6.9 kg ) for 300 mg/wk , and 7.1 kg ( 95 % CI , 6.0 to 8.2 kg ) for 600 mg/wk . The mean fat-free mass gained by the placebo groups was 0.8 kg ( 95 % CI , -0.1 to 1.7 kg ) when receiving 50 mg/wk of testosterone enanthate , 3.5 kg ( 95 % CI , 2.1 to 4.8 kg ) for 125 mg/wk , 5.7 kg ( 95 % CI , 4.8 to 6.5 kg ) for 300 mg/wk , and 8.1 kg ( 95 % CI , 6.7 to 9.5 kg ) for 600 mg/wk . The dose-adjusted differences between the dutasteride and placebo groups for fat-free mass were not significant ( P = .18 ) . Changes in fat mass , muscle strength , sexual function , prostate volume , sebum production , and hematocrit and lipid levels did not differ between groups . CONCLUSION Changes in fat-free mass in response to grade d testosterone doses did not differ in men in whom DHT was suppressed by dutasteride from those treated with placebo , indicating that conversion of testosterone to DHT is not essential for mediating its anabolic effects on muscle . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00493987 BACKGROUND Substantial loss of muscle mass occurs among men with AIDS wasting . OBJECTIVE To investigate the independent effects of testosterone therapy and progressive resistance training in eugonadal men with AIDS wasting . DESIGN R and omized , controlled trial . SETTING University hospital . PATIENTS 54 eugonadal men with AIDS wasting ( weight < 90 % ideal body weight or weight loss > 10 % ) . INTERVENTION In a 2 x 2 factorial design , patients were assigned to receive testosterone enanthate ( 200 mg/wk ) or placebo injections and progressive resistance training ( three times weekly ) or no training for 12 weeks . MEASUREMENTS Cross-sectional muscle area and other indices of muscle mass . RESULTS Cross-sectional muscle area increased in response to training compared with nontraining ( change in arm muscle mass , 499 + /- 349 mm2 vs. 206 + /- 264 mm2 [ P = 0.004 ] ; change in leg muscle mass , 1106 + /- 854 mm2 vs. 523 + /- 872 mm2 [ P = 0.045 ] ) and in response to testosterone therapy compared with placebo ( change in arm muscle mass , 512 + /- 371 mm2 vs. 194 + /- 215 mm2 [ P < 0.001 ] ; change in leg muscle mass , 1,236 + /- 881 mm2 vs. 399 + /- 729 mm2 [ P = 0.002 ] ) . Levels of high-density lipoprotein cholesterol decreased in response to testosterone therapy compared with placebo ( -0.03 + /- 0.13 mmol/L vs. 0.05 + /- 0.13 mmol/L [ -1 + /- 5 mg/dL vs. 2 + /- 5 mg/dL ] ; P= 0.011 ) and increased in response to training compared with nontraining ( 0.05 + /- 0.13 mmol/L vs. 0.00 + /- 0.16 mmol/L [ 2 + /- 5 mg/dL vs. 0 + /- 6 mg/dL ] ; P = 0.052 ) . CONCLUSIONS In contrast to anabolic therapies that may have adverse effects on metabolic variables , supervised exercise effectively increases muscle mass and is associated with significant positive health benefits in eugonadal men with AIDS wasting This study was design ed to evaluate the safety and effectiveness of testosterone therapy for clinical symptoms of hypogonadism ( low libido , low mood , low energy , loss of appetite/weight ) in human immunodeficiency virus-positive men with CD4 cell counts less than 400 cells/mm3 and deficient or low normal serum testosterone levels . The trial consisted of 8 weeks of open treatment with 400 mg of intramuscular testosterone cypionate biweekly . Responders were maintained at this dosage for another 4 weeks and then were r and omized in a double-blind , placebo-controlled , 6-week discontinuation trial . Of the 112 men who completed at least 8 weeks of treatment , 102 ( 91 % ) were rated as responders on a global assessment of sexual desire/function .  Of the 34 study completers with major depressive disorder and /or dysthymia , 79 % reported significant improvement in mood at week 8 . Average weight change was a gain of 3.7 pounds , with 45 % gaining more than 5 pounds . Eighty-four men entered and 77 completed the double-blind phase ; of these , 78 % of completers r and omized to testosterone and 13 % r and omized to placebo maintained their response . No significant medical or immunologic adverse effects were identified . Testosterone therapy was well tolerated and effective in ameliorating symptoms of clinical hypogonadism , and equally so for men with and without testosterone deficiency . For patients with major depression and /or dysthymia , improvement was equal to that achieved with st and ard antidepressants Dysfunction of the muscles of ambulation contributes to exercise intolerance in chronic obstructive pulmonary disease ( COPD ) . Men with COPD have high prevalence of low testosterone levels , which may contribute to muscle weakness . We determined effects of testosterone supplementation ( 100 mg of testosterone enanthate injected weekly ) with or without resistance training ( 45 minutes three times weekly ) on body composition and muscle function in 47 men with COPD ( mean FEV(1 ) = 40 % predicted ) and low testosterone levels ( mean = 320 ng/dl ) . Subjects were r and omized to 10 weeks of placebo injections + no training , testosterone injections + no training , placebo injections + resistance training , or testosterone injections + resistance training . Testosterone injections yielded a mean increase of 271 ng/dl in the nadir serum testosterone concentration ( to the middle of the normal range for young men ) . The lean body mass ( by dual-energy X-ray absorptiometry ) increase averaged 2.3 kg with testosterone alone and 3.3 kg with combined testosterone and resistance training ( p < 0.001 ) . Increase in one-repetition maximum leg press strength averaged 17.2 % with testosterone alone , 17.4 % with resistance training alone , and 26.8 % with testosterone + resistance training ( p < 0.001 ) . Interventions were well tolerated with no abnormalities in safety measures . Further studies are required to determine long-term benefits of adding testosterone supplementation and resistance training to rehabilitative programs for carefully screened men with COPD and low testosterone levels BACKGROUND Many men older than 50 years have bioavailable testosterone levels below the reference range for young adult men . The impact of the decreased and rogen levels on cognition and health perception has received little attention . METHODS Sixty-seven men ( mean age 76 + /- 4 years , range 65 - 87 ) with bioavailable testosterone levels below 128 ng/dl ( lower limit for adult normal range ) were r and omized to receive transdermal testosterone ( 2 - 2.5 mg patches/d ) or placebo patches for 1 year . All men received 500 mg supplemental calcium and 400 IU vitamin D. Outcome measures included sex hormones [ testosterone , bioavailable testosterone , sex hormone binding globulin ( SHBG ) , estradiol , and estrone ] , cognitive tests ( Digit Symbol , Digit Span , Trailmaking A and B ) , health perception ( Medical Outcome Survey Short-form 36 or SF-36 ) , lower extremity muscle strength and power , and calcium intake . RESULTS Twenty-three men ( 34 % ) withdrew from the study ; 44 men completed the trial .  Bioavailable testosterone levels increased from 93 + /- 34 ( SD ) to 162 + /- 100 ng/dl ( p < .002 ) at 12 months in the testosterone group ( n = 24 ) while no change occurred in the control group ( n = 20 ) . While there was no change in estradiol levels in either group , estrone levels increased in the testosterone group ( 28 + /- 7 to 32 + /- 9 pg/dl , p = .017 ) . Scores on the Digit Symbol test improved in both the testosterone and placebo groups . Scores on Trailmaking B improved in men treated with testosterone ( p < .005 ) , although the changes were not statistically different from the changes seen in the placebo group . Twelve-month scores on Trailmaking B for the entire group were correlated with 12-month testosterone levels ( p = .016 ) . Scores for health perception measured by SF-36 did not change significantly , though scores of mental and general health declined in both groups during the 12-month intervention . Twelve-month bioavailable testosterone scores were directly correlated with scores for physical role ( p = .022 ) , vitality ( p = .036 ) , and the physical composite score ( p = .010 ) . CONCLUSIONS Transdermal testosterone treatment in men with low bioavailable testosterone levels does not impair and may improve cognitive function . Treatment did not improve health perception but this may have been due to the side effects of skin irritation suggested by similar reactions in both the testosterone and placebo groups Introduction : This study investigated the effects of testosterone ( T ) treatment on cognition , mood , and quality of life in men with mild cognitive impairment ( MCI ) and low serum T levels . Methods : A total of 351 community-dwelling men were screened , and 37 men evidence d both MCI and low T of whom 27 agreed for further screening . Twenty-two met all the study inclusion /exclusion criteria and enrolled in a 6-month r and omized , double-blind , placebo-controlled study . Results : Total T levels significantly increased in the T treatment group . No significant changes were observed in measures of cognition , mood , or quality of life other than improvement in 1 objective measure of verbal memory ( P < .05 ) and decreased depression symptoms ( P < .02 ) in the treatment group . Conclusions : Testosterone treatment may modestly improve verbal memory and depression symptoms in men with both MCI and low Women experience somatic , mood , energy , and libido changes during menopause .  Testosterone replacement therapy is being prescribed in conjunction with estrogen replacement therapy ( ERT ) for these symptoms . Little is known about women ’s perceptions of the benefits and risks of testosterone , so an Internet survey was conducted to elicit women ’s perceptions of the effects on mood , energy , sexuality , and somatic symptoms .  A sample of 61 women primarily from the United States and Canada participated in the survey ; one woman from Germany and one from Sweden also took part in the survey . Participants reported significantly improved sexuality and improved mood and vigor , with a decline in fatigue . Of the 7 somatic complaints assessed , improvements were noted in 5 ( sleep disturbances , hot flashes , night sweats , vaginal dryness , and appetite ) . A prospect i ve clinical trial is needed to confirm these results
Testosterone supplementation did not show consistent benefit for cardiovascular risk , sexual function , mood and behavior , or cognition .
Studies that examined clinical cardiovascular endpoints have not favored testosterone therapy over placebo .
Testosterone is ineffective in treating erectile dysfunction and controlled trials did not show a consistent effect on libido .
Testosterone supplementation consistently increased muscle strength but did not have beneficial effects on physical function .
Most studies on mood-related endpoints found no beneficial effect of testosterone treatment on personality , psychological well-being , or mood .
Testosterone products are recommended by some prescribers in response to a diagnosis or presumption of " low testosterone " ( low-T ) for cardiovascular health , sexual function , muscle weakness or wasting , mood and behavior , and cognition .