BEDMINSTER, N.J., June 17 – New data from a 12-month,
international, multi-center study showed that treatment for low
testosterone with Tostran(R), a topical, metered dose 2% testosterone gel,
significantly improves insulin sensitivity and sexual function among
hypogonadal men with Type 2 diabetes and/or Metabolic Syndrome. These data
were presented today at the Endocrine Society’s 90th Annual Meeting in San
Francisco. Tostran, also marketed as Fortigel, Tostrex and Itnogen, is
available in 13 countries across Europe, and ProStrakan (LSE: PSK), an
international specialty pharmaceutical company, plans to file Tostran with
U.S. regulatory authorities later this year.
The Testosterone replacement In hypogonadal men with either MEtabolic
Syndrome or type 2 diabetes (TIMES 2) study looked at the effects of
Tostran on insulin resistance, diabetic control, lipids, quality of life
and symptoms of hypogonadism. The placebo-controlled study of 220
hypogonadal men met its primary endpoint by showing a statistically
significant improvement in insulin sensitivity in testosterone treated
patients at six and 12 months (p=0.05 and p=0.01, respectively), as
measured by homeostasis model assessment as an index of insulin resistance
(HOMA-IR). Further, measured by the Index of Erectile Function (IIEF),
patients using the testosterone gel saw significant improvement in sexual
function at six and 12 months (p <0.05).
“These data tell us that replacement therapy for low testosterone in
hypogonadal males not only improves sexual function but, more importantly,
can also have impact on insulin sensitivity,” said lead investigator T.
Hugh Jones BSc, MD, FRCP, Consultant Physician & Endocrinologist and Hon.
Professor of Andrology, Barnsley Hospital and University of Sheffield, UK.
“The TIMES 2 study indicates for the first time the role that testosterone
may play over the long-term in hypogonadal men with Type 2 diabetes.”
In U.S. men aged 40-69 years, it is estimated that there are about
481,000 new cases of hypogonadism per year. Overall, approximately 2.4
million U.S. men suffer from the condition.(1) Hypogonadism results from a
deficiency in testosterone secretion that may occur naturally with
increasing age, or as a result of disorders of the hypothalamus, pituitary
glands or testes. Men with the condition can experience reduced libido and
sexual function, reductions in energy and body strength, changed physique,
alterations in well-being, and reduced quality of life.(2)
“Awareness of the problems caused by low testosterone is becoming more
widespread and its connection to health issues like diabetes continues to
become increasingly apparent,” said Professor Jones. “As the incidence of
hypogonadism continues to grow along with the aging population, we need to
be acutely aware and implement a more rigorous screening program,
particularly in men with Type 2 diabetes.”
About TIMES 2
The TIMES 2 study was a randomized, double-blind, placebo-controlled,
multi-center, international study to assess the effect of daily transdermal
testosterone replacement therapy in hypogonadal men with Type 2 diabetes
and/or Metabolic Syndrome.
The primary endpoint of the study was to determine the effect of 2%
testosterone gel (Tostran) on insulin resistance in all patients. This was
measured by sampling the patients’ blood and measuring insulin and glucose
levels to calculate HOMA-IR, an index of insulin resistance. Insulin
resistance is a major biochemical defect in Type 2 diabetes and Metabolic
Syndrome. It is associated not only with the development of high blood
sugars but also with abnormalities in the lipid profile and other
biochemical changes which increase the risk of cardiovascular disease.
Secondary endpoints included: change in lipid profile and abdominal
obesity; glycemic control as measured by HbA1c; sexual satisfaction and
other quality of life scores.
The study, which was conducted in Belgium, France, Germany, Italy,
Netherlands, Spain, Sweden and the UK, recruited 220 patients who were
randomized to 2% testosterone gel treatment, or placebo gel, applied once a
day to the thigh or abdomen. The study followed patients on treatment for
one year.
About TOSTRAN
Tostran is the first metered dose 2% testosterone gel for use as
replacement therapy in male hypogonadism, a condition with serious
consequences and associations. Following its launch in Sweden in 2005,
where it has over 30 percent of the testosterone gel market, Tostran is now
available in all main European countries. ProStrakan plans to file Tostran
with the U.S. Food and Drug Administration.
About ProStrakan
Scottish-based ProStrakan is one of Europe’s fastest growing
pharmaceutical companies, with new U.S. headquarters in Bedminster, New
Jersey. Listed on the main London Stock Exchange, ProStrakan is committed
to developing innovative therapies to improve the lives of patients. Our
current products range from cancer, women’s health, men’s health,
anesthesiology, and cardiovascular disease. For more information on
ProStrakan, please visit http://www.ProStrakan-USA.com.
(1) Araujo AB et al. J Clin Endocrinol Metab, December 2004, 89 (12):
5920-5926
(2) Bhasin S et al. J Clin Endocrinol Metab, June 2006, 91 (6): 1995-2010
SOURCE ProStrakan