Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

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

21.06.2002


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 Biofilm discovery suggests new way to prevent dangerous infections
23.05.2017 | University of Texas at Austin

nachricht Another reason to exercise: Burning bone fat -- a key to better bone health
19.05.2017 | University of North Carolina Health Care

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: Can the immune system be boosted against Staphylococcus aureus by delivery of messenger RNA?

Staphylococcus aureus is a feared pathogen (MRSA, multi-resistant S. aureus) due to frequent resistances against many antibiotics, especially in hospital infections. Researchers at the Paul-Ehrlich-Institut have identified immunological processes that prevent a successful immune response directed against the pathogenic agent. The delivery of bacterial proteins with RNA adjuvant or messenger RNA (mRNA) into immune cells allows the re-direction of the immune response towards an active defense against S. aureus. This could be of significant importance for the development of an effective vaccine. PLOS Pathogens has published these research results online on 25 May 2017.

Staphylococcus aureus (S. aureus) is a bacterium that colonizes by far more than half of the skin and the mucosa of adults, usually without causing infections....

Im Focus: A quantum walk of photons

Physicists from the University of Würzburg are capable of generating identical looking single light particles at the push of a button. Two new studies now demonstrate the potential this method holds.

The quantum computer has fuelled the imagination of scientists for decades: It is based on fundamentally different phenomena than a conventional computer....

Im Focus: Turmoil in sluggish electrons’ existence

An international team of physicists has monitored the scattering behaviour of electrons in a non-conducting material in real-time. Their insights could be beneficial for radiotherapy.

We can refer to electrons in non-conducting materials as ‘sluggish’. Typically, they remain fixed in a location, deep inside an atomic composite. It is hence...

Im Focus: Wafer-thin Magnetic Materials Developed for Future Quantum Technologies

Two-dimensional magnetic structures are regarded as a promising material for new types of data storage, since the magnetic properties of individual molecular building blocks can be investigated and modified. For the first time, researchers have now produced a wafer-thin ferrimagnet, in which molecules with different magnetic centers arrange themselves on a gold surface to form a checkerboard pattern. Scientists at the Swiss Nanoscience Institute at the University of Basel and the Paul Scherrer Institute published their findings in the journal Nature Communications.

Ferrimagnets are composed of two centers which are magnetized at different strengths and point in opposing directions. Two-dimensional, quasi-flat ferrimagnets...

Im Focus: World's thinnest hologram paves path to new 3-D world

Nano-hologram paves way for integration of 3-D holography into everyday electronics

An Australian-Chinese research team has created the world's thinnest hologram, paving the way towards the integration of 3D holography into everyday...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Marine Conservation: IASS Contributes to UN Ocean Conference in New York on 5-9 June

24.05.2017 | Event News

AWK Aachen Machine Tool Colloquium 2017: Internet of Production for Agile Enterprises

23.05.2017 | Event News

Dortmund MST Conference presents Individualized Healthcare Solutions with micro and nanotechnology

22.05.2017 | Event News

 
Latest News

How herpesviruses win the footrace against the immune system

26.05.2017 | Life Sciences

Water forms 'spine of hydration' around DNA, group finds

26.05.2017 | Life Sciences

First Juno science results supported by University of Leicester's Jupiter 'forecast'

26.05.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>