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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN56557137

Enrollment

Registered

2004-04-01

Start date

1997-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism Nutritional, Metabolic, Endocrine Testicular hypofunction

Interventions

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

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: No exclusion criteria

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
No secondary outcome measures	—

Countries

China, India, Indonesia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026