Effects of testosterone treatment on body fat and lean mass in obese men on a hypocaloric diet: a randomised controlled trial

Table 4 Incidence of adverse events

	Testosterone group n = 49	Placebo group n = 51
Overall
Any adverse event	10	8
Withdrawal due to serious adverse event^a	2	1
Prostate
Rise in prostate-specific antigen by > 1.0 μg/L	5^*	0
Prostatitis	1	0
Rise in haemoglobin to > 180 g/L^b	1	0
Cardiovascular	1	1
Gastrointestinal	0	2
Dermatological	2	4
Neurological	0	1

^*P = 0.02
^aA total of three men were withdrawn from the study: one man receiving testosterone experienced angina requiring coronary artery stent insertion, one man receiving testosterone had a rise in prostate-specific antigen above the pre-determined safety level (>5.5 μg/L) at week 26, one man receiving placebo experienced ventricular fibrillation and was resuscitated
^bThe rise in haemoglobin above the pre-determined safety level (>180 g/L) occurred at study end

ISSN: 1741-7015