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

Inclusion Criteria1

  • Hypogonadism or hypopituitarism (baseline T < 2 nmol/L)

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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