Table Info

Table 1.

Baseline, study end data in the total cohort, the TU, and placebo arms

Study parameters	Total group	Placebo	TU	p (rank-sum, inter-group)
Number of men	170	94	76	-
Age median (IQR)	62.5 (55, 69)	62.5 (55, 69)	62.5 (54, 69)	0.97
Baseline serum TT (nmol/L) median (IQR)	8.8 (6.8, 11.1)	8.55 (6.6, 11.3)	9.2 (7.1, 11.0)	0.42
30-week serum TT (nmol/L) median (IQR)	9.85 (7.22, 12.7)	8.9 (6.8, 11.7)	11.5 (8.3, 13.5)	0.0089
∆serum TT (nmol/L) median (IQR), p (sign-rank, intra-group differences)	0.80 (–1.4, 2.85), p = 0.0015	0.80 (–1.40, 2.0), p = 0.10	1.3 (–1.4, 3.85), p = 0.0020	0.10
Baseline serum SHBG (nmol/L) median (IQR)	28.1 (20.5, 36.6)	27.0 (19.9, 35.7)	29.2 (20.5, 38.2)	0.53
30-week serum SHBG (nmol/L) median (IQR)	26.6 (20.3, 36.8)	26.1 (19.0, 37.6)	27.0 (20.7, 36.3)	0.83
∆serum SHBG (nmol/L) median (IQR), p (sign-rank, intra-group differences)	–1.0 (–4.4, 3.2), p = 0.082	–0.70 (–4.1, 3.5), p = 0.63	–1.2 (–4.6, 2.1), p = 0.037	0.29
Baseline serum cFT (pmol/L) median (IQR)	190 (145, 230)	182.5 (140.0, 225.0)	190 (150, 230)	0.6
30-week serum cFT (pmol/L) median (IQR)	200.0 (150.0, 257.0)	180.0 (150.0, 222.5)	227.5 (166.5, 280.0)	0.0001
∆serum cFT (nmol/L) median (IQR), p (sign-rank, intra-group differences)	10 (–30, 55), p = 0.011	5 (–30, 30), p = 0.76	37.5 (–30, 85), p = 0.0010	0.0059
Baseline AMSS median (IQR)	39 (34, 49)	39 (32, 48)	40 (34, 51)	0.23
30-week AMSS median (IQR)	36 (28, 44)	37 (29, 45)	34 (28, 44)	0.61
∆AMSS median (IQR), p (sign-rank, intra-group differences)	–3 (–9, 2), p < 0.0001	–2 (–7, 3), p = 0.010	–6 (–10, 0), p < 0.0001	0.014
Baseline HADS-D median (IQR)	7 (5, 10)	7 (4, 10)	8 (5, 10)	0.24
30-week HADS-D median (IQR)	7 (3, 9)	7 (3, 9)	6 (4, 9)	0.97
∆HADS-D median (IQR), p (sign-rank, intra-group differences)	–1 (–3, 1), p = 0.0019	0 (–1, 1), p = 0.080	–1 (–3, 0), p = 0.0083	0.072
Baseline HADS-A median (IQR)	5 (2, 8), n = 143	4 (2, 8), n = 81	5.5 (3, 8), n = 62	0.22
30-week HADS-A median (IQR)	4 (1, 7)	3.5 (1, 8)	4 (1.5, 7)	0.84
∆HADS-A median (IQR), p (sign-rank, intra-group differences)	–1 (–3, 1), p = 0.0023	0 (–1, 1), p = 0.22	–1 (–3, 0), p = 0.0010	0.072

p < 0.05 is considered significant. -: no data; ∆: changes. AMSS: ageing male symptom scale; cFT: calculated free testosterone; HADS-A: Hospital Anxiety and Depression Scale-anxiety; HADS-D: Hospital Anxiety and Depression Scale-depression; IQR: interquartile range; SHBG: sex hormone-binding globulin; TT: total testosterone; TU: testosterone undecanoate

Declarations

Acknowledgments

We acknowledge the contributions of Drs Nigel Cole, Mithun Bhartia, Jesse Raju, David Kennedy, and Peter Wilkinson for their role in conceiving, designing, data collection, statistical analysis, and preparing the original publications from the BLAST Study dataset. We would also like to thank the Primary Care Practices and the patients who took part in the study.

Author contributions

PR: Conceptualization, Writing—original draft, Writing—review & editing. MZ and CSK: Writing—original draft. JM: Writing—original draft, Visualization. SR: Conceptualization, Writing—original draft, Writing—review & editing, Visualization. GH: Conceptualization, Writing—original draft. All authors have read and agreed to the published version of the manuscript.

Conflicts of interest

The author declares that there are no conflicts of interest.

Ethical approval

BLAST study obtained ethics approval from the Multi centre UK Research Ethics Committee (08/H1208/30).

Consent to participate

Informed consent to participate in the study was obtained from all participants.

Consent to publication

Not applicable.

Availability of data and materials

The datasets that support the findings of this study are available from Professor Sudarshan Ramachandran upon reasonable request.

Funding

The practice expenses (BLAST RCT) of the research are supported by a grant from Bayer plc [BSP-SOP-040]. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The authors did not receive any support from any organization for the submitted work. No funding was received to assist with the preparation of this manuscript.

Copyright

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