Management of the australianclinicaltrials.gov.au website has been transferred from NHMRC to the Commonwealth Department of Health. Disruption to site users as a consequence of this change should be minimal.

Clinical Trial Details

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

Print record Print record
Trial Information

Broad Health Condition Metabolic and Endocrine

Specific Health ConditionDiabetes

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/06/2005

Anticipated date of last participant enrolment1/06/2005

Phase of TrialPhase 4

Has the study received ethics approval?Further information iconApproved

Trial 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

Key inclusion criteria

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

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

No exclusion criteria
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Department of Endocrinology, St Vincents Hospital Sydney
Primary Sponsor Country: Australia

Trial IDACTRN12605000482662

Contact person for information and recruitment
Dr Ken Ho
Professor of Medicine Head Pituitary Research Unit Garvan Institute Chairman Department of Endocrinology Garvan Institute of Medical Research St Vincent's Hospital 384 Victoria Street Darlinghurst NSW 2010
+61 2 92958203
+61 2 92958411
Further information iconk.ho@garvan.unsw.edu.au
Australia