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!

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: First diode for magnetic fields

Innsbruck quantum physicists have constructed a diode for magnetic fields and then tested it in the laboratory. The device, developed by the research groups led by the theorist Oriol Romero-Isart and the experimental physicist Gerhard Kirchmair, could open up a number of new applications.

Electric diodes are essential electronic components that conduct electricity in one direction but prevent conduction in the opposite one. They are found at the...

Im Focus: Nonstop Tranport of Cargo in Nanomachines

Max Planck researchers revel the nano-structure of molecular trains and the reason for smooth transport in cellular antennas.

Moving around, sensing the extracellular environment, and signaling to other cells are important for a cell to function properly. Responsible for those tasks...

Im Focus: UNH scientists help provide first-ever views of elusive energy explosion

Researchers at the University of New Hampshire have captured a difficult-to-view singular event involving "magnetic reconnection"--the process by which sparse particles and energy around Earth collide producing a quick but mighty explosion--in the Earth's magnetotail, the magnetic environment that trails behind the planet.

Magnetic reconnection has remained a bit of a mystery to scientists. They know it exists and have documented the effects that the energy explosions can...

Im Focus: A Chip with Blood Vessels

Biochips have been developed at TU Wien (Vienna), on which tissue can be produced and examined. This allows supplying the tissue with different substances in a very controlled way.

Cultivating human cells in the Petri dish is not a big challenge today. Producing artificial tissue, however, permeated by fine blood vessels, is a much more...

Im Focus: A Leap Into Quantum Technology

Faster and secure data communication: This is the goal of a new joint project involving physicists from the University of Würzburg. The German Federal Ministry of Education and Research funds the project with 14.8 million euro.

In our digital world data security and secure communication are becoming more and more important. Quantum communication is a promising approach to achieve...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Optical Coherence Tomography: German-Japanese Research Alliance hosted Medical Imaging Conference

19.11.2018 | Event News

“3rd Conference on Laser Polishing – LaP 2018” Attracts International Experts and Users

09.11.2018 | Event News

On the brain’s ability to find the right direction

06.11.2018 | Event News

 
Latest News

Helping to Transport Proteins Inside the Cell

21.11.2018 | Life Sciences

Meta-surface corrects for chromatic aberrations across all kinds of lenses

21.11.2018 | Power and Electrical Engineering

Removing toxic mercury from contaminated water

21.11.2018 | Life Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>