Lawley bio-identical research and clinical trials are happening around the world
Lawley Pharmaceuticals is contributing to pioneering research using the bio-identical hormones testosterone, progesterone and estradiol.
Currently we have clinical trials underway using our bio-identical products in the Australian cities of Sydney, Melbourne, Perth and Adelaide and also in the USA in Boston, MA and Butler Hospital, RI.
The diverse range of conditions we are researching illustrates the far reaching effects hormones have on our health and quality-of-life.
Alzheimer’s Disease: The Role of Testosterone and Fish Oil in the deposition ß-amyloid in Alzheimer’s Disease. Principal Investigator: Professor Ralph Martins. The McCusker Alzheimer Disease Research Foundation, Inc., Perth, Australia. Summary: ß-amyloid is the protein that builds up in the brain in Alzheimer’s Disease patients. Animal studies have shown testosterone reduces the build up of this protein in the brain. Our study is a world-first human study examining testosterone use in at-risk patients with a view to preventing the onset and progression of Alzheimer’s Disease. Study sponsor: Lawley Pharmaceuticals. This study is now recruiting. For further information see www.talz.com.au
IVF: Use of transdermal testosterone cream in IVF pre-treatment and its effect on controlled ovarian stimulation and IVF outcome in poor responder IVF patients: A randomized placebo-controlled trial. Principal Investigators: Dr Shlomi Barak, Prof Susan Davis, Prof Robin Bell Melbourne IVF and School of Public Health, Monash University, Australia. This study is examining the effect of higher testosterone levels pre-IVF treatment with the aim of increasing the effectiveness of IVF/ICSI and therefore the live birth rate. Study product: AndroFeme®. This study is now recruiting. For further information see www.mivf.com.au
Dry Eyes: Pilot Study of the Effects of Testosterone and Oestradiol Therapy Compared to Placebo on Clinical Indicators and Biomarkers of Dry Eye in Post-Menopausal Women. Principal Investigator: Prof Fiona Stapleton, School of Optometry and Vision Science, UNSW, Sydney, Australia. Dry eyes is a common complaint of hormone replacement therapy in the management of menopausal symptoms. This study is exploring the effects of testosterone, oestrogen and a combination of oestrogen and testosterone transdermal treatment on ocular symptoms, ocular surface sensitivity, clinical indicators and bio-markers of dry eye in post-menopausal women. Study product: AndroFeme®. This study is now fully recruited and expected to be completed in August 2013.
Male Health: The Pharmacokinetics of AndroForte® Compared With AndroGel® (Testogel®) in Androgen Deficient Men Principal Investigator: Prof Gary Wittert School of Medicine, University of Adelaide. This study compared Lawley’s AndroForte® 5 testosterone cream against market leader transdermal testosterone gel TestoGel®. The study has been completed and demonstrated bio-equivalence. Publication of this study is expected in late 2013. An additional study examining the pharmacokinetics, long-term clinical efficacy and prostate safety after scrotal application is planned to commence in 2014. Study product: AndroForte® 5. For further information contact email@example.com
Women’s Health: An open-label, single centre,randomised,cross-over study of two doses of AndroFeme® in healthy postmenopausal women. Principal Investigators: Prof Susan Davis, Ms Ensieh Fooladi and Prof Robin Bell Monash University, Women’s Health Program, Melbourne, Australia. This study is examining the pharmacokinetic variables of two doses of AndroFeme® testosterone cream for women. The hormone testosterone contributes to libido and well-being in women. Multiple studies of testosterone therapy in pre- and postmenopausal women with low testosterone levels and reduced libido have demonstrated improvements in sexual desire. This study is now recruiting. For further information see www.womenshealth.med.monash.edu.au
Women’s Health: Collaborative Study: Testosterone Antidepressant Augmentation in Women. Principal Investigator: 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 email KKMiller@partners.org .