Men. Healthier Together.
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Our clinical research program focuses on new areas of treatment for which there has been little or no pharmaceutical investigation and where existing preparations have short-comings. Many conditions such as post natal depression, endometriosis, female androgen deficiency including female sexual dysfunction (FSD), male androgen deficiency and polycystic ovarian syndrome have underlying states of hormonal imbalance.
Inclusion body myositis (IBM) is the most common acquired skeletal muscle disease associated with aging. The cause is not known, there is no cure and it affects men more often than women. The condition is progressive resulting in muscle weakness and wasting including muscles used for breathing and swallowing. The impact on health-related quality of life is considerable. A key intervention, to help prevent loss of muscle mass and maintain strength, is exercise tailored to the individual. In healthy men the combination of testosterone and exercise has been shown to increase muscle strength performance and increase physical activity overall. Accordingly, in this study we propose to examine the effect testosterone treatment administered transdermally in addition to an exercise program for men affected by IBM.
AIMS / RESEARCH QUESTION
Status: Study completed Jan 2019. Analysis of results underway.
1 year Extension Study under consideration.
A 2x2 factorial randomised controlled trial which will look at how testosterone and exercise could improve fitness and increase physical activity as well as improve the function of blood vessels.
Status: Study completed October 2018. Analaysis of results underway.
Lead Investigators: A/Prof Bu Yeap, University of Western Australia, Fiona Stanley Hospital, Western Australia.
Description: Testosterone combined with exercise training improves limb muscle strength and performance more than either alone. However, this combination has not been tested for its effects on fitness and blood vessels. This study will examine whether testosterone and exercise training improves the function of blood vessels more than either alone.
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Pharacokinetics of Testosterone cream applied to scrotal skin.
Status: Fully recruited and completed. Published July 2017 at www.ncbi.nlm.nih.gov/pubmed/28334510Z
Lead Investigator: Professor David Handelsman, ANZAC Research Institute, Concord, Sydney
Description: The conventional use of testosterone cream, gel and solutions has been to the upper body in testosterone deficient men. Due to low absorption residual testosterone can be transferred to partners and children via contact. This study examines the absorption of testosterone cream when applied to scrotal skin which opens the potential to avoid passive transfer problems.
Status: Study completed July 2018, accepted for publication April 2020
Principal Investigators: Assoc Prof Karen K Miller MD Harvard Medical School, Neuroendocrine Unit, Massachusetts General Hospital, Boston, USA.
This study is an 8-week randomized, placebo-controlled study of the effects of low-dose testosterone vs. placebo in 100 women with SSRI-resistant depression using AndroFeme® testosterone cream. This study is due to commence in July 2013. For further information contact KKMiller@partners.org.
Study Centres: Neuroendocrine Unit, Massachusetts General Hospital, Boston, USA and Butler Hospital, Rhode Island, USA.
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