RecruitingPhase 4ACTRN12605000482662

How androgens exert their anabolic effects. Interaction of testosterone and growth hormone at the hepatic level.

How androgens exert their anabolic effects: Interaction of testosterone and growth hormone at the hepatic level in men with hypogonadism or hypopituitarism.


Sponsor

Department of Endocrinology, St Vincents Hospital Sydney

Enrollment

36 participants

Start Date

Jun 1, 2005

Study Type

Interventional

Conditions

Summary

Observations from previous studies suggest that the full action of GH requires the presence of male hormones like Testosterone (T). We will test the hypothesis that T enhances GH effect acting on the liver. We will compare the body protein production after delivering T exclusively to the liver (capsules) and to peripheral tissues (patch). The first phase (11 weeks, 6 visits) aims to find the T dose which exposes the liver to normal/physiological T levels. The second phase (16 weeks, 5 visits) will compare the effect of delivering T to the liver and to peripheral tissues.


Eligibility

Sex: Males

Plain Language Summary

Simplified for easier understanding

This study is looking at how testosterone (the main male sex hormone) works together with growth hormone to build body protein. Previous research suggests that testosterone may enhance the effects of growth hormone, particularly in the liver. This trial compares two ways of delivering testosterone — directly to the liver (via capsules) versus to the rest of the body (via a skin patch) — in men who have low testosterone levels due to a hormone condition. You may be eligible if: - You are male - You have been diagnosed with hypogonadism (low testosterone) or hypopituitarism (underactive pituitary gland) - Your baseline testosterone level is below 2 nmol/L You may NOT be eligible if: - There are no additional exclusion criteria listed beyond the inclusion requirements Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

oral micronised testosterone 5 - 40 mg daily for 2 - 5 periods of 14 days. transdermal testosterone (Androderm) 5mg daily for 1 -3 periods of 14 days. recominant human growth hormone (GH)(Humatrope)

oral micronised testosterone 5 - 40 mg daily for 2 - 5 periods of 14 days. transdermal testosterone (Androderm) 5mg daily for 1 -3 periods of 14 days. recominant human growth hormone (GH)(Humatrope) 0.5 mg daily for 18 weeks (GH deficient subjects only!)


Locations(1)

Australia

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ACTRN12605000482662