| Ischemia/Angina |
| Acute Intravenous Treatment |
|
Rosano et al, 1999[12] |
14 men 45–66 years old with coronary artery disease (CAD). |
2.5 mg testosterone (T) or intravenous (IV) placebo over 5 min, 30 min prior to exercise test; tx switch at 2 days; randomization by computer; masking not described. |
↑Time to ST segment depression. ↓Maximum ST segment depression. ↓ST recovery. |
3 |
|
Ong et al, 2000[9] |
22 men with CAD. |
2.3 mg T or placebo IV over 10 min (n = 11) with switch after 1 week; 0.023–0.046 mg T or placebo IV over 10 min (n = 11) with tx switch after 1 week; randomization method not given. |
↑Percent change in brachial artery diameter after release of occlusion with high-dose T. No change in flow velocity in brachial artery after release of occlusion. Low-dose T had no effect. Interpreted as enhanced response to local effects of nitric oxide after T. |
3 |
|
Thompson et al, 2002[8] |
34 men 69 ± 6 years old (mean ± SD) with CAD and exercise- or adenosine-inducible ischemia. |
T or placebo by bolus IV over 20 min with maintenance IV to increase basal serum T concentration 0, 2-, or 6-fold with each subject receiving all 3 conditions randomly 1 week apart; randomization method not given. |
No effect on time to ST segment depression or myocardial perfusion defects by SPECT. No effect on time to angina in the 5 subjects who experienced angina during testing. |
4 |
|
Webb et al, 1999[2] |
14 men 35–75 years old with CAD and plasma T concentration ≤ 11 nM (317 ng/dL). |
2.3 mg T or placebo IV over 10 min 30 min prior to exercise test; 1 week later under tx switch; randomization method not given. |
↑Time to ST segment depression. No change in maximum ST segment depression or in time to onset of angina. |
4 |
| 2–24 Week Treatment Period |
|
Dohn et al, 1968[13] |
44 men with leg claudication or ulcers attributed to arteriosclerosis (n = 43) or Buerger’s diseas (n = 1). Two men did not complete study, but numbers in tables add to 86 subjects. Not possible to tell for sure how many men were analyzed. |
300 mg aqueous T isobutyrate or placebo (meprobamate) every 14 days for 3 months; route of administration not given; double-blind; randomization method not given. |
No effect on subject improvement, walking test, plethysmographic estimation of pulse volume, blood flow at rest or after exercise, or hyperemia after compression. ↑Skin temperature. |
3 |
|
Ly et al, 2001[11] |
37 men mean age 68.2 years with plasma T concentration ≤15 nM (432 ng/dL); 4 dropouts were excluded from analysis. |
70 mg dihydrotestosterone (DHT) gel (n = 18) or placebo (n = 19) applied daily for 3 months; randomization method not given. |
No effect on flow- or nitroglycerin-mediated dilatation of brachial artery. |
5 |
|
Kang et al, 2002[10] |
35 men mean age 58 years with CAD. |
160 mg testosterone undecanoate PO daily for 4 weeks then 80 mg daily for 8 weeks (n = 18); placebo tx (n = 17) not given; randomization method not given. |
↑Flow- and nitroglycerin-mediated dilatation of brachial artery. |
1 |
|
Malkin et al, 2004[1] |
12 men 60.8 ± 4.6 years old (mean ± SD) with CAD and “clinical need for T replacement.” One man failed screening and another withdrew at unspecified point in the study. |
100 mg T or placebo IM every 2 weeks for 4 weeks, 1 month washout, then tx switch; randomization by computer; single-blind. |
↑Time to ST segment depression. No significant change in Seattle Angina Score. ↓Beck Depression Inventory (BDI) score. |
5 |
|
Jaffe, 1977[14] |
50 men 35–71 years old with post-exercise ST segment depression. |
200 mg T cypionate (n = 25) or placebo IM (n = 25) weekly for 8 weeks, randomization method not given. Described as double-blinded. |
↓Sum of ST segment depression in leads II, V4, 5, and 6 at 0, 2, 4, and 6 min after exercise. Symptoms not evaluated. |
4 |
|
Cornoldi et al, 2009[15] |
87 men 57–74 years old with chronic angina, CAD, or prior myocardial infarction (MI). |
40 mg T undecanoate (n = 43) or placebo (n = 44) PO TID for 12 weeks; double-blind; randomization by computer. |
↓Incidence of silent myocardial infarction. ↓Total ischemic burden. ↓Number of anginal attacks/week. |
5 |
|
English et al, 2000[16] |
50 men mean age 62 years with stable CAD. |
5 mg daily T patch (n = 25) or placebo (n = 25) for 12 weeks; double-blind; randomization method not given. Three withdrawals from T arm and 1 withdrawal from placebo arm eliminated from analysis. |
↑Time to ST-segment depression by week 14. No change in angina frequency. Improved quality of life (QoL) scores. |
4 |
|
Webb et al, 2008[3] |
25 men 40–75 years old with angiographically proven CAD (≥70% lesion in at least one major coronary artery or major branch), plasma T concentration ≤12 nM (346 ng/dL); 2 dropouts prior to medication tx were not analyzed. One subject had unanalyzable data. |
160 mg/day T undecanoate or placebo PO for 8 weeks followed by tx switch. Method of randomization not given. |
No change in global myocardial perfusion by magnetic resonance imaging (MRI). ↑Perfusion of segments supplied by coronary arteries without significant obstruction. ↑Left ventricular (LV) ejection fraction (EF) (by 2%). No change in stroke volume (SV), end-systolic volume (ESV), end-diastolic volume (EDV), or heart mass. |
4 |
|
Basaria et al, 2010[17] |
209 men ≥65 years old with total serum T 100–350 ng/dL (3.5–12.1 nM) or free serum T <50 pg/mL (174 pM) and with mobility limitations. Analysis restricted to 176 men with a baseline assessment and at least one outcome assessment. |
100 mg T (n = 106) or placebo (n = 103) gel daily for 6 months. After 2 weeks, dose level was increased or decreased by 50% based on serum T. Randomization was by age blocks but was not otherwise described. |
↑Cardiovascular-related adverse events (AEs), adjusted OR 5.8, 95% CI 2.0–16.8 (includes acute coronary syndrome [ACS]–chest pain, syncope, MI, stroke, congestive heart failure [CHF] exacerbation, coronary stenting and bypass procedures, peripheral edema, elevated blood pressure [BP], arrhythmias, ECG changes). |
5 |
|
Wu et al, 1993[7] |
62 men 55–75 years old with angina. |
120 mg T undecanoate PO QD × 2 weeks then 40 mg/day × 2 weeks or placebo for 2 weeks followed by 2-week washout, then tx switch; described as randomized, but there were 31 men in each group and randomization was not described. |
↓Ischemia on ECG and Holter recordings by subjective scoring system. ↓Angina by subjective scoring system. |
2 |
| ≥12-Month Treatment Period |
|
Mathur et al, 2009[4] |
15 men 64.8 ± 7 years old (mean ± SD) with stable chronic angina, ST segment depression at baseline, and at least 2 early morning serum T concentrations < 12 nM (346 ng/dL); one man assigned to each arm withdrew at unspecified point in the study. |
1000 mg T undecanoate depot IM (n = 6) or placebo (n = 7) q 3 months × 12 months; randomized by computer; described as double-blind. |
↑Time to ST segment depression at 14, 28, and 52 weeks and increased level of exercise attained. No significant change in Seattle Angina Score (SAS). |
4 |
|
Kenny et al, 2002 [5] |
67 men 65–87 years old (mean 74) with bioavailable T <4.44 nM (128 ng/dL); 23 dropouts (10 T, 13 placebo) and 8 men with technical difficulties were not included in the analysis. |
5 mg daily T patch (n = 34) or placebo (n = 33) × 12 months. Randomization method not described. |
No change in vascular reactivity after occlusion. |
3 |
|
Basaria et al, 2015[6] |
Men aged 60 years or older, morning total T 100–400 ng/dL (3.5–14 nM) or free <50 testosterone pg/mL (1.7 pM). 1:1 concealed randomization with stratification by age dichotomized at 75 years and by site. Computer-generated randomization. All subjects receiving at least 1 medication dose were retained for analysis. |
3 years of daily application of 75 (n = 155) or 0 (n = 151) mg testosterone as a gel, dose level adjusted upwards or downwards based on total testosterone 2–12 hours after gel application. Placebo adjusted by an unblinded observer. 44/155 receiving T did not complete, 23 for adverse events; 51/151 receiving placebo did not complete, 17 for adverse events. |
No difference in carotid artery intima-media thickness or in rate of thickening over time; No difference in coronary artery calcium score change over time |
5 |
| Congestive Heart Failure |
|
Caminiti et al, 2009[18]; Schwartz et al, 2011[87] |
70 men 66–76 years old (mean age 70) with stable CHF (NYHA II or III) and LV Ef <40%. Dropouts (4 on T and 2 on placebo) and lost data (1 on T and 5 on placebo) were not included in analysis. |
1000 mg T undecanoate (n = 35) or saline (n = 35) IM at 6 and 12 weeks. Subjects said to be randomized, but randomization method was not given. |
↑Distance in 6-minute walk test. ↑Body mass index (BMI). ↑O2 consumption. ↓Ventilation/CO2 output. ↓Diastolic BP. No change in EF or LV end-diastolic diameter.[18] ↓QT interval (0.8%) and ↓QTc interval (1.5%).[87] |
4 |
|
Pugh et al, 2003[19] |
12 men 48–82 years old with stable CHF; 8 men characterized as having ischemic heart disease, 2 had dilated cardiomyopathy, 1 had hypertension, and 1 had alcohol-related heart failure. |
60 mg T or placebo given buccally followed the next day by tx switch. Described as randomized, but randomization method not given. |
Cardiac index was positively correlated and systemic vascular resistance negatively correlated with serum free T concentration. T attenuated the fall in cardiac index and the rise in systemic vascular resistance associated with the catheterization procedure. No effect of tx on pulmonary capillary wedge pressure. Another report of this trial found no effect on serum concentration of TNF-α.[21] |
3 |
|
Pugh et al, 2004[20] |
20 men 44–81 years old with impaired LV EF (mean 35%). |
100 mg T or placebo IM every 2 weeks for 12 weeks. Subjects said to be randomized, but randomization method and number of subjects per group not given. |
Distance walked was increased more by T than by placebo. T improved heart failure symptom scores compared to baseline. There was no improvement after placebo. There were no effects of T on LV size, or EF. |
3 |
|
Malkin et al, 2006[23] |
76 men with CHF, mean age ~64 years; 34 dropouts were retained for analysis using ITT. |
5 mg T (n = 37) or placebo (n = 39) patch daily for 12 months; randomization stratified by ischemic vs non-ischemic heart failure. Method of randomization not given. |
15% improvement in distance on shuttle walk test. More subjects on T (35%) than placebo (8%) improved in NYHA class. |
3 |
|
Mirdamadi et al 2014[22] |
50 males, age 50–70, with CHF. |
T enanthate 250 mg IM or saline placebo IM every 4 weeks for 12 weeks. |
No difference between groups in blood pressure (SBP or DBP), ejection fraction, or other cardiovascular end points assessed by echocardiography. A Doppler-based myocardial performance index improved in the treatment group. |
3 |
| Lipids |
| Favorable Effects on Lipids |
|
Uyanik et al, 1997 [155] |
37 healthy men 53–89 years old. |
120 mg daily T undecanoate (n = 17) or placebo (n = 20) PO for 2 months. |
↓Total serum cholesterol (12%). ↓LDL cholesterol (20.7%). No change in HDL cholesterol or triglycerides. |
0 |
|
Tenover, 1992[156] |
13 healthy men 57–76 years old with serum T ≤13.9 nM (400 ng/dL). |
100 mg T enanthate or placebo IM weekly x 3 months followed by tx switch x 3 months; described as randomized, but randomization procedure not described. Six subjects received T first. |
↓Total serum cholesterol (11%). ↓LDL cholesterol (12%). No effect on HDL cholesterol, apolipoprotein A-1, or triglycerides. |
4 |
|
Ly et al, 2001[11] |
37 men mean age 68.2 years with plasma T concentration ≤15 nM (432 ng/dL); 4 dropouts were excluded from analysis. |
70 mg dihydrotestosterone (DHT) gel (n = 18) or placebo (n = 19) applied daily for 3 months; method of randomization not discussed. |
↓Total serum cholesterol (~10%). ↓LDL cholesterol (~10%). No change in HDL cholesterol or triglycerides. |
5 |
|
Howell et al, 2001[24] |
35 men, mean age 40.9 years after cancer chemotherapy; serum luteinizing hormone ≥8 IU/L and serum T < 20 nM (576 ng/dL); 2 subjects did not complete the study; it is not known if they were included in analysis. |
2.5 mg T (n = 16) or placebo (n = 19) patch daily for 2–4 weeks then dose increased to 2 patches daily for remainder of 12 months unless serum T >20 nM; randomization method not given. |
↓LDL cholesterol (13%) for periodic measurements averaged over months 3–12. No change in triglycerides, LDL cholesterol, HDL cholesterol. |
3 |
|
Malkin et al, 2004[27] |
29 men 36–78 years old with a clinical indication for T replacement for hypogonadism; 2 subjects were withdrawn and 2 additional patients did not contribute analyzable sera. |
100 mg T (n = 27) or placebo IM (n = 27) every 2 weeks; randomization using blocks of computer-generated numbers. A crossover design appears likely, although not explicit. |
↓Total serum cholesterol (6%). ↓Triglycerides (11%). No effect on LDL or HDL cholesterol. |
5 |
|
Malkin et al, 2004[1] |
12 men 60.8 ± 4.6 years old (mean ± SD) with CAD and “clinical need for T replacement”; one man failed screening, one man withdrew at unspecified point in the study. |
100 mg T or placebo IM every 2 weeks for 4 weeks, washout for 1 month, then opposite tx; order of tx randomized by computer; described as single-blinded. |
↓Total serum cholesterol (6%). No effect on LDL or HDL cholesterol or triglycerides. |
5 |
|
Kapoor et al, 2006[157] |
27 men, 52–76 years old (mean age 54 years) with type 2 diabetes mellitus (T2DM) and total T <12 nM (346 ng/dL) with symptoms attributed to hypogonadism; 3 men were excluded due to protocol violations. |
200 mg sustanon (30 mg T propionate, 60 mg T phenylpropionate, 60 mg T isocaproate, and 100 mg/mL T decanoate) or placebo IM every 2 weeks for 6 injections followed by a 1-month washout period followed by tx switch; randomization by computer-derived random number table; number in each arm not stated. |
↓Total serum cholesterol (5%). No effect on LDL or HDL cholesterol or triglycerides. |
5 |
|
Mathur et al, 2009[4] |
15 men 64.8 ± 7 years old (mean ± SD) with stable chronic angina, ST segment depression at baseline, and at least 2 early morning serum T concentrations < 12 nM (346 ng/dL); one man assigned to each arm withdrew at unspecified point in the study. |
1000 mg T undecanoate depot IM (n = 6) or placebo (n = 7) q 3 months for 12 months; randomized by computer; described as double-blind. |
↓Triglycerides (% change not available). No effect on total or HDL cholesterol. |
4 |
|
Cornoldi et al, 2010[15] |
87 men 57–74 years old with chronic angina, CAD, or prior MI. |
40 mg T undecanoate (n = 43) or placebo (n = 44) PO TID for 12 weeks; double-blind; randomization by computer. |
↓Serum total cholesterol (7%). ↓Triglycerides (14%). No effect on HDL cholesterol. |
5 |
|
Gianatti et al 2014[32] |
88 men age 35–70 years of age with a history of type 2 diabetes mellitus (T2DM) and total testosterone ≤12.0 nM (346 ng/dL). 13 men did not complete the study, 8 because of intensification of oral hypoglycemic agents or commencement of insulin therapy. 1 subject in testosterone group was withdrawn with a hematocrit of >54 prior to his 30 week injection. |
Participants were randomly assigned in a concealed 1:1 allocation to T or placebo using permuted blocks with a block size of 4. IM T undecanoate 1000 mg (n = 45) or placebo (n = 43) at 0, 6, 18, and 30 weeks. |
↓Total cholesterol (12%); ↓ LDL cholesterol (13%); ↑ HDL cholesterol (9%); No change in triglycerides |
4 |
|
Hackett et al 2014[158] |
199 Men aged 18–80 with T2D with a total T 8.1–12 nM (234–346 ng/dL) or total T of ≤8.0 nM (231 ng/dL). 9 patients did not complete the study; 4 because of serious adverse events (3 treatment unrelated deaths, 1 prostate cancer in placebo) and 5 withdrew their consent. |
Subjects were block randomized to receive T undecanoate IM at 0 (n = 102) or 1000 (n = 97) mg at week 0, 6, and 18. |
↓Total cholesterol (6%); No change in LDL or HDL cholesterol or triglycerides |
5 |
| Lack of Favorable Effects on Lipids |
|
Kang et al, 2002[10] |
35 men mean age 58 years with CAD. |
160 mg T undecanoate PO daily for 4 weeks then 80 mg daily for 8 weeks (n = 18). Placebo tx (n = 17) not described. Randomization method not given. |
No effect on total HDL and LDL cholesterol or on triglyceride serum concentration. |
1 |
|
Kenny et al, 2002[5] |
67 men 65–87 years old (mean 74) with bioavailable T <4.44 nM (128 ng/dL); 23 dropouts (10 T, 13 placebo) not included in the analysis. |
5 mg daily T patch (n = 34) or placebo (n = 33) for 1 year. Randomization method not described. |
↓HDL (9%) and HDL2 (15%) cholesterol. No change in total, LDL cholesterol, triglycerides, or lipoprotein-a (LP-a). |
3 |
|
Chung et al, 2007[61] |
30 healthy men 18–45 years old. |
200 mg T (n = 10), nonandrolone (n = 10), or placebo IM (n = 10) weekly for 4 weeks; computer-generated randomization list with block design. |
No effect on total, LDL, or HDL cholesterol or triglyceride serum concentrations. |
5 |
|
Kouri et al, 1996[159] |
16 healthy men 20–43 years old. |
T cypionate IM (150 mg at weeks 1 and 2 [n = 8], 300 mg at weeks 3 and 4 [n = 8], and 600 mg at weeks 5 and 6 [n = 8]) or placebo followed by 6-week washout followed by opposite tx and another 6-week washout. Described as randomized, procedure not given. |
↓HDL cholesterol (21%). No effect on LDL cholesterol. |
3 |
|
Jockenhövel et al, 1999[25] |
55 men with hypogonadism (serum T concentration <3.6 nM [105 ng/dL]); androgen therapy withdrawn 3 months prior to study in men using such therapy. |
Randomized by unspecified method to mesterolone (n = 12; not further discussed here), T undecanoate 160 mg/day PO (n = 13), T enanthate (n = 15) 250 mg IM every 21 days, T subcutaneous pellet 200 mg implanted once (n = 15). Open label. |
↑Total serum cholesterol (6–20%). ↑LDL cholesterol (47–65%). ↓HDL cholesterol (33–36%). ↑Triglycerides (23–46%). |
1 |
|
Snyder et al, 2001[160] |
108 healthy men over 65 years old (mean age 73 years) with serum T concentration at least 1 standard deviation below the mean for young men (16.5 nM [476 ng/dL]). |
6 mg daily scrotal T patch (n = 54) or placebo (n = 54); dose could be reduced to 4 mg daily if serum T >1000 ng/dL (34.7 nM). Study described as randomized and double-blinded; randomization method not discussed. |
No effect on serum concentrations of total, HDL, or LDL cholesterol, triglycerides, apolipoprotein B, apolipoprotein A-1, or LP-a. |
4 |
|
Webb et al, 2008[3] |
25 men 40–75 years old with angiographically proven coronary heart disease (≥70% lesion in at least one major coronary artery or major branch), plasma T concentration ≤12 nM (346 ng/dL); 2 dropouts prior to medication tx were not analyzed. One subject had unanalyzable data. |
160 mg/day T undecanoate or placebo by mouth for 8 weeks followed by crossover to the other tx. Allocation of tx order not discussed. |
↓HDL cholesterol (9%). No change in total or LDL cholesterol or triglycerides. |
4 |
|
Agledahl et al, 2008[161] |
27 men, average age 69 years and serum T <11.0 nM (317 ng/dL); 1 dropout excluded from analysis. |
1000 mg T undecanoate (n = 14) or placebo (n = 13) IM at 0, 6, 16, 28, and 40 weeks; randomization method not discussed. |
No effect at 52 weeks on postprandial serum triglycerides, chylomicron triglycerides, free fatty acids, lipoprotein lipase, or hepatic lipase after a fatty meal. |
2 |
|
Emmelot-Vonk et al, 2008[91] |
237 healthy men 60–80 years old with T concentration below the median; ie, <13.7 nM (395 ng/dL); 30 dropouts, 16 of whom provided some follow-up information. |
160 mg T undecanoate (n = 120) or placebo (n = 117) by mouth daily for 6 months; randomization by computer-generated list using blocks of 6. |
No effect on total, HDL, or LDL cholesterol or triglycerides. |
5 |
|
Kalinchenko et al, 2010[162] |
184 men, 35–69 years old, with metabolic syndrome and T concentration <12.0 nM (346 ng/dL); 14 dropouts were eliminated from analysis. |
1000 mg T undecanoate (n = 113) or placebo (n = 71) IM at 0, 6, and 18 weeks; randomization method not discussed, tx arms were intentionally uneven. |
No difference in total, HDL, or LDL cholesterol or in triglycerides. |
4 |
|
Jones et al, 2011[26] |
220 men, mean age 59.9 years, with metabolic syndrome or T2DM or both and total T ≤11 mM (317 mg/dL) or free T <255 pM (7.3 ng/dL); 54% of subjects completed the study, ITT analysis used last observation carried forward. |
60 mg T (n = 108) or placebo (n = 112) gel for 12 months; randomization stratified by presence of metabolic syndrome only, diabetes mellitus (DM) only, and DM with metabolic syndrome; dose levels adjusted based on T measurements. |
↓LP-a (23–27%) at months 6 and 9; no difference at month 12; No difference in total, HDL, or LDL cholesterol or in triglycerides |
4 |
|
Paduch et al, 2015[78] |
Sexually active men 26 or more years old with ejaculatory dysfunction and total T < 300 ng/dL (10.41 nM). |
T solution applied to axilla daily at 60 (n = 39) or 0 (n = 35) mg/day, titrated up or down based on serum T concentration after 4 weeks. Computer randomization scheme on a 1:1 basis. Five subjects in each group discontinued, 1 in T group due to adverse event. |
No differences in total, LDL, or HDL cholesterol or triglycerides |
5 |
|
Basaria et al, 2015[6] |
Men aged 60 years or older, morning total T 100–400 ng/dL (3.5–14 nM) or free <50 testosterone pg/mL (1.7 pM). 1:1 concealed randomization with stratification by age dichotomized at 75 years and by site. Computer-generated randomization. All subjects receiving at least 1 medication dose were retained for analysis. |
3 years of daily application of 75 (n = 155) or 0 (n = 151) mg testosterone as a gel, dose level adjusted upwards or downwards based on total testosterone 2–12 hours after gel application. Placebo adjusted by an unblinded observer. 44/155 randomized to T did not complete, 23 for adverse events; 51/151 receiving placebo did not complete, 17 for adverse events. |
No differences in total, LDL, or HDL cholesterol or triglycerides |
5 |
|
Asih et al, 2015[163] |
50 men ≥50 years old complaining of memory problems (44 completed) Randomization by random numbers table. |
T transdermal 50 (n = 22) or 0 (n-22) applied to the scrotum daily for 24 weeks; after a 4-week washout, patients were crossed over to the other arm |
No differences in total, HDL, or LDL cholesterol. |
5 |
| Inflammatoryand Coagulation Markers |
|
Ng et al, 2002[33] |
37 healthy men >60 years of age with serum T concentration <15 nM (432 ng/dL); 4 dropouts were excluded from analysis. |
DHT gel 70 mg/day (n = 18) or placebo (n = 19) for 3 months. |
No effect on C-reactive protein, soluble intracellular adhesion molecule-1, or soluble vascular cell adhesion molecule-1. |
4 |
|
Malkin et al, 2004[27] |
29 men 36–78 years old with a clinical indication for T replacement for hypogonadism; 2 subjects were withdrawn and 2 additional patients did not contribute analyzable sera. |
100 mg T (n = 27) or placebo IM (n = 27) every 2 weeks; randomization using blocks of computer-generated numbers. A crossover design appears likely, although not explicit. |
↓Serum tumor necrosis factor-α (TNF-α). ↑Interleukin-10 (IL-10). No change in IL-1β (identified as decreased by authors, but not statistically significant). |
5 |
|
Malkin et al, 2004[1] |
12 men 60.8 ± 4.6 years old (mean ± SD) with CAD and “clinical need for T replacement”; one man failed screening, one man withdrew at unspecified point in the study.[19] |
100 mg T or placebo IM every 2 weeks x 4 weeks, 1 month washout, then tx switch; randomization by computer; described as single-blinded. |
↓Serum TNF-α. |
5 |
|
Smith et al, 2005[34] |
61 men with CAD recruited, 50 completed screening and placebo run-in phase. Four subjects withdrew and were excluded from analysis. |
5 mg T or placebo patches applied each night. |
No change in plasma fibrinogen, plasminogen activator inhibitor-1, or tissue plasminogen activator at 6 or 14 weeks tx. |
3 |
|
Pugh et al, 2005[21] |
12 men 48–82 years old with stable CHF (same group reported on in 2003)[19] |
60 mg T or placebo given buccally followed the next day by tx switch. Described as randomized, but randomization method not given. |
No effect on serum concentration of TNF-α with any of these T tx. |
3 |
| 20 men with NY Heart Association class II or III CHF, mean age 63.9 years in the active group and 61.1 years in the placebo group. |
100 mg T (n = 10) or placebo (n = 10) IM every 2 weeks for 12 weeks. Subjects said to be randomized, randomization method not given. |
3 |
| 62 men with NY Heart Association class II, III, or IV CHF, mean age 63.1 years in the active group and 64.9 years in the placebo group. |
5 mg T (n = 37) or placebo (n = 39) patch applied daily for 12 weeks. Randomization method not given. |
3 |
|
Kapoor et al, 2007[31] |
20 men, 52–76 years old (mean age 63 years) with T2DM and total T <12 nM (346 ng/dL) or bioavailable T <4 nM (115 ng/dL) with symptoms attributed to hypogonadism; 4 men were excluded due to technical problems with measurement. |
200 mg Sustanon (30 mg T propionate, 60 mg T phenylpropionate, 60 mg T isocaproate, and 100 mg/mL T decanoate) or placebo IM every 2 weeks for 6 injections followed by a 1-month washout followed by tx switch; tx order randomized by computer-derived random number table; number in each arm not stated. |
No effect on C-reactive protein. |
5 |
|
Webb et al, 2008[3] |
25 men age 40–75 with angiographically proven CAD (≥70% lesion in at least one major coronary artery or major branch), plasma T concentration ≤12 nM (346 ng/dL); 2 dropouts prior to medication tx were not analyzed. One subject had unanalyzable data. |
160 mg/day T undecanoate or placebo by mouth for 8 weeks followed by tx switch. Randomization method not given. |
No change in plasminogen activator-1, fibrinogen, or factor VII. |
4 |
|
Guler et al, 2006[28] |
41 men with CAD who underwent stenting. |
3 weekly IM doses of T (n = 25; Sustanon 250 = T propionate 30 mg, phenylproprionate 60 mg, isocaproate 60 mg, and decanoate 100 mg); 3-week interval before stenting with usual tx (n = 16). Described as double-blind, but no placebo injection discussed. Randomization method not given. |
24 hours after stenting,↓interleukin-6 (IL-6), ↓C-reactive protein. No effect on TNF-α. |
2 |
|
Nakhai-Pour et al, 2007[29] |
237 men age 60–80 with serum T concentration below the population median (13.7 nM); 14 were lost to follow-up. |
160 mg daily T undecanoate 160 mg/day (n = 113) or placebo (n = 110). Randomization methods not given. |
No effect of tx on C-reactive protein, except ↑ in men with baseline C-reactive protein concentration below the median. |
5 |
|
Frederiksen et al, 2012[30] |
38 men age 60–78 with free T concentration <7.3 nM finished the study. Number starting not given. |
Unspecified dose of T gel or placebo used for 6 months. |
↓Osteoprotegerin. No change in C-reactive protein. |
3 |
|
Gianatti et al, 2014[32] |
88 men age 35–70 years of age with a history of T2DM and total testosterone ≤12.0 nML (346 ng/dL). 13 men did not complete the study, 8 because of intensification of oral hypoglycemic agents or commencement of insulin therapy. 1 subject in testosterone group was withdrawn with a hematocrit of >54 prior to his 30 week injection. |
Participants were randomly assigned in a concealed 1:1 allocation to T or placebo using permuted blocks with a block size of 4. IM T undecanoate 1000 mg (n = 45) or placebo (n = 43) at 0, 6, 18, and 30 weeks. |
No change in CRP concentration. |
4 |
