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The men were randomised to Weight Watchers weight loss programme plus placebo versus the same weight loss programme plus testosteronegel, placebo only for a period of 2 weeks. The men were randomly allocated to receive the pill twice a day before dinner and to the testosterone gel three times a day for the first week followed by a wash out period. All volunteers underwent two studies during a period of 10 weeks in which they lost 9.7kg. The trial was approved by the Medical Research Council ethics committee and all the studies were registered in the UK Clinical Trials Registry.After the two study periods, the testosterone gel was withdrawn and no further research was carried out. The men who started testosterone followed one protocol for a 1.5 year maintenance period from when they commenced treatment. This protocol had a lower placebo/testicular dosage and had different administration regimes. Volunteers were then asked to return to their habitual weight. If they were unable to decrease from a BMI of 27.6 kg/m2 to 16.6 kg/m2 they were advised to drop back into the normal weight range by changing from the diet to a normal diet.All subjects were assessed for the primary risk factor of obesity and, according to our assessment, each subject was classified as an extreme obese subject, as the maximum BMI for men over 30 kg/m2 and as being at or very close to obesity level 1 on the basis of the BMI. In the overall analysis, the three groups of men who achieved a BMI of 27.6 kg/m2 or greater during the two study periods did not differ significantly in weight loss: the weight loss group gained significantly more weight than the weight gain group (weight difference in kilograms = -10.6, 95% confidence interval [CI] -18.6 to -20.1; P = 0.0018). There was a significant weight difference (P = 0.0045) between the placebo and placebo-treated groups in the post-treatment period, showing that the testosterone treatment induced weight loss in the testosterone group was higher than that achieved by the placebo group. This difference in weight loss was not attributable to weight gain over the follow-up period. The participants who achieved a BMI of 30 kg/m2 or greater during the two study periods did not differ significantly in weight loss from those who achieved a BMI of 27.6 kg/m2, suggesting that there was no difference in the amount of weight lost between the two groups. Weight loss in the men who achieved a BMI of 27.6 kg/m2 was significantly longer than that lost by the men who achieved the normal weight range, atSimilar articles: