None listed
Conditions
Brief summary
The T4ADS study will investigate whether androgen deficiency-like symptoms, such as decreased sense of well-being, energy, libido, motivation, improve following 6 weeks of testosterone (T) gel application significantly more than during 6 weeks of placebo gel treatment. The study will run at the Department of Andrology, CRGH and will aim to recruit 40 men with possible androgen deficiency-like symptoms from the local community. Men 40 and over will be invited to join the study if they or their own doctor believe they have androgen deficiency. Volunteers interested in participation will be screened for eligibility by medical history, physical examination and blood tests. Eligible and consenting participants will be randomised at enrolment to receive either T or placebo gel as their first 6 week treatment and the alternative gel in the second treatment period. The third 6 week treatment period will let the men chose which gel they prefer to use. Study visits will be over a total of 27 weeks. It is hoped that androgen deficiency-like symptoms improve significantly following 6 weeks of T gel application than during 6 weeks of placebo gel treatment. We would also like to determine whether pre-treatment blood T levels predict a superior response to T compared to placebo and whether the participants preferred treatment, either T or placebo is reproducible when the preferred treatment remains blinded.
Interventions
Eligible participants will visit the study centre 11 times over a 27 week period. They will be randomised to receive either daily Testosterone gel 1% (Androgel) or a placebo gel in the first 6 week treatment period and the alternative gel in the second treatment period. The men will chose which gel they prefer to use for the third treatment period. There will be a 3 week washout period between each treatment period.
The gel is delivered in a pump pack. Pushing the pump 6 times will deliver 7.5 m
Eligible participants will visit the study centre 11 times over a 27 week period. They will be randomised to receive either daily Testosterone gel 1% (Androgel) or a placebo gel in the first 6 week treatment period and the alternative gel in the second treatment period. The men will chose which gel they prefer to use for the third treatment period. There will be a 3 week washout period between each treatment period. The gel is delivered in a pump pack. Pushing the pump 6 times will deliver 7.5 mg of gel (i.e. 50mgs testosterone) and is to be applied at about the same time each day preferably in the morning to clean, dry healthy skin on the trunk. Treatment period 1 -. He will receive 3 containers of the gel which he will apply daily for 6 weeks. During this time he will return for 2 visits at 3 and 6 weeks which will involve blood collection for safety and research purposes and completion of health questionnaires. At the 6 week visit the empty gel bottles are returned Wash out period 1 – 3 weeks of no treatment Treatment period 2 - he will receive 3 containers of the alternate gel which he will apply daily for 6 weeks. During this time he will return for 2 visits at 3 and 6 weeks which will involve blood collection for safety and research purposes and completion of health questionnaires. At the 6 week visit the empty gel bottles are returned. Wash out period 2 – 3 weeks of no treatment Treatment period 3 – participant will choose which gel he preferred in the first or second treatment period and will be given his choice of gel to use for another 6 week period. As at the other treatment visits there will be blood collection for safety and research purposes and completion of health questionnaires.
Sponsors
Department of Andrology, Concord Repatriation General Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
Male
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Men aged 40 years or older Believed to have androgen deficiency (AD) Symptoms consistent with AD (according to US clinical guidelines) Provides written, informed consent and is willing to comply with study requirements
Exclusion criteria
Pathologically-based AD Major chronic illness causing serious disability or with life expectancy less then 2 years in the opinion of the investigator Major cardiovascular event (new or worsened angina, infarction, angioplasty, uncontrolled arrhythmia or hypertension) within the last 6 months Contraindication to testosterone including prostate or breast cancer. History of androgen or other drug abuse within last year. History of HIV or viral hepatitis. Skin disease that may interfere with transdermal drug administration. History of major psychiatric disease or psychological condition that may limit understanding and compliance with study requirements. Regular use of medications that interfere with absorption, metabolism or action of testosterone and may require dosage change during the study. Haematocrit over 0.50 or history of polycythaemia
Outcome results
None listed