Navigation Links
Novel Testosterone Gel Significantly Improves Insulin Sensitivity and Sexual Function in Hypogonadal Men With Type 2 Diabetes and Metabolic Syndrome
Date:6/17/2008

New Data Highlights the Need for Testosterone Screening in At-Risk

Hypogonadal Men

BEDMINSTER, N.J., June 17 /PRNewswire/ -- 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
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Fox Chase Cancer Center and VisEn Medical Announce Program to Advance First Clinical Trials of Novel Fluorescence Molecular Imaging Technologies
2. European Enrollment Begins in Pivotal Phase 3 Trial of Novel Combination Medicine Developed by Cogentus Pharmaceuticals
3. Pharmacyclics Novel Btk Inhibitor Shows Efficacy in Preclinical Models of Rheumatoid Arthritis and Lymphoma
4. New Data on MAGE-A3 Cancer Immunotherapy Support Potential Novel Options of Treating Non-Small Cell Lung Cancer and Melanoma
5. BiPar Sciences Expands Clinical Development of BSI-201, A Novel PARP Inhibitor, With Phase 2 Trial in Uterine Cancer
6. Forest and Almirall Announce Positive Results of Clinical Studies for Aclidinium Bromide, a Novel, Long-Acting Anticholinergic for the Treatment for COPD
7. deCODE Discovers Novel Genetic Links Between Pigmentation Traits and Risk of Skin Cancer
8. Velcura Therapeutics, Inc. Reports Successful Phase 1 Clinical Trial of Novel Bone Disease Therapy
9. Cytopia Announces Novel Anti-Cancer Drug Development Collaboration
10. BiPar Sciences Expands Phase 2 Clinical Trials of BSI-201, a Novel DNA Repair Inhibitor, in Ovarian Cancer
11. Latest Cell Publication Describes the Novel Kinase Regulators Using OriGenes Functional Kinome Collection
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA:CTIC) today ... U.S. Food and Drug Administration (FDA) on February 4, ... hold on the clinical studies being conducted under the ... clinical hold impacts part of the clinical work currently ... planned clinical trials. --> ...
(Date:2/5/2016)... IRVINE, Calif. , Feb. 5, 2016 /PRNewswire/ ... leading global aesthetic device company, announced today that ... Syneron Candela North America, is scheduled to participate ... Global Healthcare Conference on February 11, 2016 in ... conference will allow institutional investors to meet with ...
(Date:2/5/2016)... http://www.researchandmarkets.com/research/jsc97m/global ) ... "Global Musculoskeletal Partnering 2010-2016: Deal trends, players ... offering. --> http://www.researchandmarkets.com/research/jsc97m/global ) ... "Global Musculoskeletal Partnering 2010-2016: Deal trends, players ... offering. --> Research and ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... February 08, 2016 , ... Remember the old saying “rub some ... to Perry A~, author of “Calcium Bentonite Clay” the health benefits of integrating clay ... and detoxifying the body. , A former motivational speaker, Perry A~ has since dedicated ...
(Date:2/8/2016)... (PRWEB) , ... February 08, 2016 , ... ... greater than 50% lower incidence rate of type 2 diabetes in the GrassrootsHealth ... ”It is time to make a change in public health,” states Carole Baggerly, ...
(Date:2/8/2016)... ... ... Guruji Mahendra Kumar Trivedi is offering 3 days of accelerated personal growth ... on February 10th. During this time, people can achieve better health, greater wealth, ... from over 40 different countries as an “ordinary man with an extraordinary gift.” ...
(Date:2/7/2016)... Birmingham, Lake Orion, Clarkston, Metamora, Michigan (PRWEB) , ... February 07, ... ... women on Friday in recognition of National Wear Red Day. National Wear Red ... heart disease and stroke in women. Heart disease and stroke cause 1 in 3 ...
(Date:2/6/2016)... (PRWEB) , ... February 06, 2016 , ... US Sports ... Coaching Conference (YUCC) . This event brings together top non-profit leaders, ultimate organizations, and ... and Girls Ultimate”. Valerio Iani, Bay Area Disc Program Director of Youth and Education, ...
Breaking Medicine News(10 mins):