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Trial details imported from ClinicalTrials.gov
Ethics application status
The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly
The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly
Universal Trial Number (UTN)
Diet and Nutrition
Other diet and nutrition disorders
Description of intervention(s) / exposure
Treatment: Drugs - testosterone undecanoate
Treatment: Drugs: testosterone undecanoate
Intervention code 
Comparator / control treatment
Primary outcome 
SF-36 quality of life scores (composite physical component score and composite mental component score).
Secondary outcome 
Secondary outcome 
Secondary outcome 
Secondary outcome 
Functional status (living arrangements, activities of daily living and frailty scale scores)
Secondary outcome 
Key inclusion criteria
- Men and women aged 65 years or older who are under-nourished, as defined by a Mini
Nutritional Assessment (MNA) score <24 AND 1 or more of the following: *a body mass
index (BMI) of less than 22 kg/m2; *weight loss of > 7.5% in the 3 months before
enrolling in the study
- Living independently in the community (not in a hospital, nursing home or hostel)
- Understand and sign informed consent document, able to communicate with the
investigator, and understand and comply with the requirements of the study.
- Women who are taking oestrogen or other hormone replacement therapy (HRT) may take
part (see exclusion criteria for exceptions), as may women who are not taking HRT. If
a woman is taking HRT she must have been on a stable dose for at least 3 months before
enrolment in the study. If not on HRT, she must not have been taking it for at least 3
months before enrolment.
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Dementia as indicated by a Folstein’s Mini Mental State Examination (MMSE) score of <
- Elevated haematocrit (HCT) levels (>50%)
- Past or present history of prostatic cancer in men (Prostate Specific Antigen (PSA)
levels [> age-related normal range and/or irregular prostate on prostate examination])
or breast cancer.
- Pre-existing androgenic signs or symptoms in women of concern to either subject or
investigator (deep voice, hirsutism, acne, androgenic hair loss).
- Depression (Yesavage Geriatric Depression Scale (GDS) Score > 11)
- Inability to attend DEXA scan or complete other requirements of the study
- Significant cardiac failure (NYHA Class III and above)
- Significantly abnormal liver function tests (ALT, GGT, bilirubin or ALP more than 2
times the upper limit of normal)
- Nephrotic syndrome; 24h urine protein excretion > 3 grams (if baseline urinalysis
reveals > 1+ proteinuria, quantification will be performed) AND/OR calculated
creatinine clearance (by the equation of Baracskay and Jarjoura for ambulatory elderly
subjects [Cr clearance = 4.4/serum creatinine (mmol/L) + (88-age)](63) < 30 ml/min)
AND/OR serum creatinine concentration > 0.2mmol/l.
- Amputee (body mass index, creatinine clearance and body composition estimations
- Any disease, which in the opinion of the investigator is likely to lead to death
within one year
- Testosterone or other androgen therapy (including DHEA and tibolone) in the four
months before starting the study.
- Medication with cyclosporin or barbiturates
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) 
University of Adelaide
Other collaborator category 
Ethics application status
The purpose of this study is to determine what effect treatment for one year with
testosterone and a nutritional supplement, alone and combined, has on the adverse effects of
under-nutrition in community-dwelling older men and women.
Trial related presentations / publications
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Ian M Chapman, MBBS, PhD
University of Adelaide