Study Authors

Intervention

Comparators/Control

Cardiovascular Risks Benefits

Adverse Effects

Mortality

Al-Qudimat, et al., 2021

IM TU every 12 weeks

Untreated

Reduction in TG, WC, BMI, FLI

T-25 (7.8%)

C- 28 (15.2%)

Alwani, et al., 2021

IM TU 1000 mg every 12 weeks

Untreated

Improvement in wt, WC, BMI, ED, BP, PR, HbA1c, TG, T-Chol, HDL

No MACE recorded

NR

Anderson, et al., 2016

Different T formulation (gel, injection & oral pills)

Untreated

Normal TRT to those with persistently low T

HR: 0.74, CI 0.56-0.98, P = 0.04

Higher MACE & death with age < 65 years with low T

3-year rates of death (4.3%) and MACE (6.6%)

Aversa, et al., 2010

IM TU 1000 mg every 12 weeks

PLB

Improvement in WC, CIMT, hs-CRP, HOMA-IR

T- mild erythrocytosis (3)

PLB – MI (1)

NR

Aversa, et al., 2012

IM TU 1000 mg every 12 weeks

Untreated

Reduction in hs-CRP, WC

NR

NR

Basaria, et al., 2015

7.5g of T gel with variation in dosing

PLB

No difference in CIMT & Carotid calcium scores

No difference in MACE

T- Stroke (2), MI (1)

T- 2

PLB - 3

Francomano, et al 2014a

IM TU 1000 mg every 12 weeks

Untreated

Improvement in wt, WC, BP,  HbA1c, HOMA-IR, T-Chol, HDL

Increased haematocrit, PSA although within acceptable limits

NR

Francomano, et al., 2014b

IM TU 1000 mg every 12 weeks

Untreated

Improvement in EF, DF, CIMT, Fibrinogen, microalbuminuria, T-Chol, endo fn.

No MACE recorded

NR

Groti, et al., 2018

IM TU 1000 mg every 10 weeks

PLB

Improvement in FMD, CIMT, WC, BMI, HbA1C, HOMA-IR, T-Chol

No MACE recorded

NR

Groti, et al., 2020a

IM TU 1000 mg every 10 weeks

PLB for the first year only

NR

No adverse CV events or PAEs

NR

Groti, et al., 2020b

IM TU 1000 mg every 10 weeks

PLB for the first year only

Reduction in the FPG, HbA1c, HOMA-IR, CIMT improved FMD, lipid profile

No adverse events or side effects observed

NR

Hackett, et al., 2013

IM TU 1000 mg at 0, 6, 18 weeks then dosage during open label unspecified

PLB for the first 30 weeks, then 106 (from both T & PLB received medication unspecified

Improved ED

No significant Adverse effects, Injection related pain

No assessment for MACE

Death unrelated to TRT

Hackett, et al., 2014

IM TU 1000 mg at 0, 6, 18 weeks then dosage during open label unspecified

PLB for the first 30 weeks, then 106 (from both T & PLB received medication unspecified

Reduction in Wt, WC, BMI and improvement in HOMA-IR

Mild Adverse effects- injection site pain

No MACE recorded

NR

Hackett, et al., 2018

IM TU given and some changed to T gel

PLB /Untreated

Reduced mortality with those with Normal T & TRT treated with age > 64.5 years and Wt < 93.8 kg

Mortality

T treated -6.2%, 0% on continuous treatment,

Untreated – 16.9%

Hackett, et al., 2020

IM TU 1000 mg at 0, 6, 18 weeks then dosage during open label unspecified

PLB/Untreated

Continuous reduction in visceral fat & decrease in WC seen in the follow up phase

No difference in non-fatal MACE between U- (19.8/1,000 years) and treated with T (15.2/1,000 years)

NR

Haider, et al., 2014

IM TU 1000 mg every 12 weeks

Untreated

Improvement in WC, Wt, BMI, BP, HbA1c, lipid profile

No Mace recorded

NR

Haider, et al., 2016

IM TU 1000 mg every 12 weeks

Untreated

Decrease in Wt, BMI, WC, HrtR, PR, BP, HbA1c, lipid pattern

No MACE recorded

NR

Heufelder, et al., 2009

Transdermal 50 mg T gel daily

Untreated

Improvement in HbA1c, FPG, HDL, TG, WC

NR

NR

Jones, et al., 2011

Transdermal (60 mg) 2% T gel daily

PLB daily

Reduction in HOMA-IR, HbA1C, Lpa, LDL, T-chol

Erythema, pruritus and nasopharyngitis CV events

T- 4.6%

PLB- 10.7%

NR

Maggi, et al., 2016

Different T formulations (gel, patch & injection)

Untreated

NR

MACE similar in T &U.

MI (14), DVT (13), stroke (9)

T-3

U-2

Sharma, et al., 2015

Different T formulations  dosing (injection, gel & patch)

Untreated

Decreased all-cause death, stroke and MI in normalized T group

High CVD cohort recruited

NR

Shores, et al., 2012

Different T formulations & dosing (IM cypionate & enanthate- 2 weekly; gel and patches)

Untreated

NR

NR

T- 41 (10.3%)

U- 131 (20.7%)

Vigen, et al., 2013

Different T formulations (gel, patch & injection)

Untreated

NR

MACE: T-25.7% ; U- 19.9%

T- 67(5.47%)

U- 681 (9.09%)