CompletedPhase 4ACTRN12616000577415

Effects of testosterone on urea metabolism in men with hypogonadism

Sponsor

Western Sydney Local Health District

Enrollment

8 participants

Start Date

Jan 16, 2015

Study Type

Interventional

Conditions

Hypogonadism

Summary

Patients with diagnosed hypogonadism will be studied at baseline and then after 2 weeks of testosterone replacement initiation at usual therapeutic doses (10 g Testogel). The study will involve measurements of urea metabolism, and whole body protein breakdown and oxidation, and how much of the amino acids are being recycled for new protein synthesis.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 75 Yearss

Inclusion Criteria3

Diagnosed hypogonadism;
Adequate replacement of other hormones in case of hypopituitarism;
Able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study

Exclusion Criteria8

Any acute condition or exacerbation of chronic conditions that in the investigators opinion would interfere with the trial visit schedule and procedures;
Cancer, diabetes mellitus, immunosuppressive steroid therapy and chronic renal or hepatic illnesses;
People in existing dependent or unequal relationships with any member of the research team;
People who may be involved in illegal activity;
People highly dependent on medical care;
Patients who had received an investigational new drug within the last 6 month;
Patients with a cognitive impairment, an intellectual disability or a mental condition which interfere with the patient's ability to understand the requirements of the study;
Inability to give written informed consent.

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Interventions

Participants are studied at baseline, and then after two weeks of transdermal testosterone (Testogel; Besins Healthcare Australia Pty Ltd, 10mg /g) administration on upper back/shoulders at a dose of

Participants are studied at baseline, and then after two weeks of transdermal testosterone (Testogel; Besins Healthcare Australia Pty Ltd, 10mg /g) administration on upper back/shoulders at a dose of 100 mg/day once daily in the morning. Adherence will be monitored by empty drug packet return.