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.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000482662

Acronym

oral testosterone study

Enrollment

Registered

2005-09-23

Start date

2005-06-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

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) 0.5 mg daily for 18 weeks (GH deficient subjects only!)

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

No exclusion criteria

Outcome results