New formulation of testosterone undecanoate in hypogonadal men: a pharmacokinetic and pharmacodynamic study of a novel formulation of testosterone undecanoate in hypogonadal Asian men

INTERVENTION: Study participants will be randomised to receive a single administration (injection) of one of the following: 1. 500 mg of the novel TU formulation 2. 1000 mg of the novel TU formulation 3. 1000 mg of 125 mg/ml TU in tea seed oil 4. 1000 mg of 250 mg/ml TU in caster oil. CONDITION: Hypogonadism ; Nutritional, Metabolic, Endocrine ; Testicular hypofunction PRIMARY OUTCOME: 1. Circulating concentrations of testosterone at 12 weeks; 2. Profile of testosterone concentrations over time at 12 weeks; 3. Gonadotropin concentrations at 12 weeks SECONDARY OUTCOME: No secondary outcome measures INCLUSION CRITERIA: 1. Male participants age 18 to 50 years 2. Diagnosed with hypogonadism (androgen values below the normal range for the centre) 3. Not concurrently undergoing other androgen therapy