Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:


Testosterone gel (AndroGel®) study demonstrates safety and efficacy up to 42 months


Long-term use of AndroGel®, a transdermal testosterone replacement gel, is safe and effective in men with low testosterone up to 42 months

A Phase 3 study conducted at multiple research centers in the U.S. under the direction of Ronald Swerdloff, MD, Principal Investigator at the Research and Education Institute at Harbor-UCLA Medical Center (REI) shows that long-term use of AndroGel®, a transdermal testosterone replacement gel, is safe and effective in men with low testosterone.
Scientists reported their results today at the 84th Annual Meeting of The Endocrine Society.

"This study represents a new milestone in the treatment of men with low testosterone," said Christina Wang, MD, REI Investigator in the Division of Endocrinology, Metabolism & Nutrition and Director, Harbor-UCLA General Clinical Research Center. "It is the first study to demonstrate that long-term use of testosterone gel replacement is both safe and effective. Because hypogonadism requires continuous treatment, it is important to understand the effects of testosterone replacement therapy over an extended period of time."

The U.S. Food and Drug Administration (FDA) estimates that four to five million American men have low testosterone, but only about five percent are currently treated. It is also estimated that low testosterone affects about one in 10 men between the ages of 40 and 60 and more than two in 10 men over the age of 60. Low testosterone, also called hypogonadism, is linked with conditions such as diminished interest in sex, erectile dysfunction (ED), osteoporosis, reduced lean body mass, depressed mood and fatigue.

In the trial, led by REI investigators, 92 hypogonadal men, with an average age of 52, received continuous replacement with testosterone gel for up to 42 months (average 29 months). Initially, each man was treated with one percent testosterone gel (AndroGel®) at 5 or 10 grams per day, with a dose adjustment to 7.5 grams per day in some men at three months to maintain testosterone levels in a normal range. There were no significant differences in age, ethnicity, body weight or height among the groups receiving different amounts of AndroGel®. AndroGel® is manufactured by Unimed Pharmaceuticals, Inc., a wholly owned, independently operated subsidiary of Solvay Pharmaceuticals, Inc.

The study showed that sexual motivation and performance significantly improved in men receiving testosterone gel at six months and this was maintained throughout treatment. Fat mass continued to decrease over the course of the treatment period (with an average decrease of 2.5 kilograms, or 5.5 pounds, at 30 months) and lean (nonfat) body mass, increased (with an average increase of 3.5 kilograms, or 7.7 pounds, at 30 months). Bone mineral density also increased by six months and remained significantly increased by about 4% in the spine and 2% in the hip at 30 months of treatment. . Daily application of the testosterone replacement gel only caused minimal skin irritation. There were minimal other side effects.

The Research & Education Institute at Harbor-UCLA Medical Center, located on the campus of Harbor-UCLA Medical Center in Torrance, California, is a leading independent, not-for-profit biomedical research institute with an international reputation for scientific discovery, the training of physician-scientists and the provision of community service programs. It is an affiliate of both the David Geffen School of Medicine at UCLA and the Harbor-UCLA Medical Center and has an annual budget of $58 million. The Institute traces its roots back to 1952, when researchers and physicians joined forces with the UCLA School of Medicine on the campus of what was then known as Harbor General Hospital to conduct a handful of research studies. Today, more than 1,000 research projects and clinical trials are being conducted at REI, advancing scientific understanding in order to improve medical outcomes and promote innovation in such areas as autoimmune disorders, cancer, cardiovascular disease, developmental disorders and other pediatric health problems, diabetes, infectious disease, inherited disorders, male contraception, vaccine evaluation and research, and various aspects of women’s health.

Barbara Kerr | EurekAlert!

More articles from Health and Medicine:

nachricht NIH scientists describe potential antibody treatment for multidrug-resistant K. pneumoniae
14.03.2018 | NIH/National Institute of Allergy and Infectious Diseases

nachricht Researchers identify key step in viral replication
13.03.2018 | University of Pittsburgh Schools of the Health Sciences

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Tiny implants for cells are functional in vivo

For the first time, an interdisciplinary team from the University of Basel has succeeded in integrating artificial organelles into the cells of live zebrafish embryos. This innovative approach using artificial organelles as cellular implants offers new potential in treating a range of diseases, as the authors report in an article published in Nature Communications.

In the cells of higher organisms, organelles such as the nucleus or mitochondria perform a range of complex functions necessary for life. In the networks of...

Im Focus: Locomotion control with photopigments

Researchers from Göttingen University discover additional function of opsins

Animal photoreceptors capture light with photopigments. Researchers from the University of Göttingen have now discovered that these photopigments fulfill an...

Im Focus: Surveying the Arctic: Tracking down carbon particles

Researchers embark on aerial campaign over Northeast Greenland

On 15 March, the AWI research aeroplane Polar 5 will depart for Greenland. Concentrating on the furthest northeast region of the island, an international team...

Im Focus: Unique Insights into the Antarctic Ice Shelf System

Data collected on ocean-ice interactions in the little-researched regions of the far south

The world’s second-largest ice shelf was the destination for a Polarstern expedition that ended in Punta Arenas, Chile on 14th March 2018. Oceanographers from...

Im Focus: ILA 2018: Laser alternative to hexavalent chromium coating

At the 2018 ILA Berlin Air Show from April 25–29, the Fraunhofer Institute for Laser Technology ILT is showcasing extreme high-speed Laser Material Deposition (EHLA): A video documents how for metal components that are highly loaded, EHLA has already proved itself as an alternative to hard chrome plating, which is now allowed only under special conditions.

When the EU restricted the use of hexavalent chromium compounds to special applications requiring authorization, the move prompted a rethink in the surface...

All Focus news of the innovation-report >>>



Industry & Economy
Event News

Virtual reality conference comes to Reutlingen

19.03.2018 | Event News

Ultrafast Wireless and Chip Design at the DATE Conference in Dresden

16.03.2018 | Event News

International Tinnitus Conference of the Tinnitus Research Initiative in Regensburg

13.03.2018 | Event News

Latest News

A new kind of quantum bits in two dimensions

19.03.2018 | Physics and Astronomy

Scientists have a new way to gauge the growth of nanowires

19.03.2018 | Materials Sciences

Virtual reality conference comes to Reutlingen

19.03.2018 | Event News

Science & Research
Overview of more VideoLinks >>>