Table 1: Characteristics of included studies.
Study Authors |
Type of Hypogonadism |
Study design |
Study duration |
Age ±SD in years |
Number of participants |
Pharma-ceutical funding |
Al-Qudimat, et al., 2021 |
LOH |
Prospective |
8 years |
59 ± 9.5 |
496 T-312, U-184
|
No |
Alwani, et al., 2021 |
Functional Hypogonadism |
Prospective cohort |
8 years |
60.7 ± 5.0 |
622 T-77, U-545
|
No |
Anderson, et al., 2016 |
LOH |
Retrospective cohort |
742 days |
61.2 ± 8.7 |
4,736 T-4,079 U- 657
|
No |
Aversa, et al., 2010 |
LOH |
RCT |
24 months |
57 ± 8 |
50 T-40, PLB-10
|
No |
Aversa, et al., 2012 |
LOH |
RCT |
36 months |
58 ± 10 |
60 T-40, U-20
|
No |
Basaria, et al., 2015* |
LOH |
RCT |
4.5 years |
67.6 ± 5.2 |
306 T-155, PLB- 151
|
Yes |
Francomano, et al. 2014a |
Functional Hypogonadism |
Prospective cohort |
60 months |
58 T-58 ± 10, U- 57 ± 8 |
40 T-20 U-20
|
No |
Francomano, et al., 2014b |
Functional hypogonadism |
Prospective cohort |
54 weeks |
T- 56 ± 9 U-53 ± 8 |
24 T-12, U-12
|
No |
Groti, et al., 2018 |
Functional Hypogonadism |
RCT |
12 months |
60.2 ± 7.2 |
55 T-28, PLB-27
|
No |
Groti, et al., 2020a |
Functional hypogonadism |
Two-part Prospective |
2 years |
60.2 ± 7.2 |
55 T-28, PLB-27
|
No |
Groti, et al., 2020b |
Functional hypogonadism |
Two-part Prospective |
2 years |
60.2 ± 7.2 |
55 T-28, PLB-27
|
No |
Hackett, et al., 2013 |
Functional hypogonadism |
RCT with open label extension |
82 weeks |
61.6 ± 9.9 |
190 T-92, PLB-98
|
No |
Hackett, et al., 2014 |
Functional hypogonadism |
RCT with open label extension |
82 weeks |
61.6 ± 9.9 |
190 T-92, PLB-98
|
No |
Hackett, et al., 2018 |
Functional hypogonadism |
RCT with follow up extension |
12.7 ± 9.1 months with follow up of 4.0 ± 1.0 years |
63.6 ± 11.6 |
857 T-175 PLB- 682 |
Yes |
Hackett, et al., 2020 |
Functional hypogonadism |
RCT with open label with 4 years’ follow-up
|
82 weeks + (4 years follow-up) |
T-61.7 U-61.9 |
199 T- 123, U- 110 |
Yes |
Haider, et al., 2014 |
Functional Hypogonadism |
Prospective cohort
|
5 years |
59.1 ± 6.1 |
181 |
No |
Haider, et al., 2016 |
LOH |
Prospective cohort |
7.3 ± 1.2 years
|
61 ± 5 |
77 |
No |
Heufelder, et al., 2009 |
Functional hypogonadism |
RCT |
52 weeks |
T-57.3 ± 1.4 U-55.9 ± 1.5
|
32 T-16 U-16 |
No |
Jones, et al., 2011 |
Functional hypogonadism |
RCT |
12 months |
59.9 ± 9.3 |
220 T-108 PLB-112
|
Yes |
Maggi, et al., 2016 |
LOH |
Prospective cohort |
36 months |
59.1 ± 10.5 |
999 T-750, U-249
|
No |
Sharma, et al., 2015 |
LOH |
Retrospective cohort |
15 years |
66.5 T-66, U-67 |
83,010 T-69,632. U- 13,378
|
No |
Shores, et al., 2012 |
LOH |
Retrospective cohort |
60 months |
61.2 ± 10.6 |
1,031 T-398 U- 633
|
No |
Vigen, et al., 2013 |
LOH |
Retrospective cohort |
531 days |
T-60.6 ± 7.6 U-63.8 ± 9.0 |
8,709 T-1223 U-7486 |
No |
LOH: Late-Onset Hypogonadism; PLB: Placebo; RCT: Randomized Controlled Trial; SD: Standard Deviation; T: Testosterone; U: Untreated; *Included those with low-normal serum Testosterone