Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Testosterone gel (AndroGel(R)) study first to show long-term benefits and safety

04.05.2004


Improvements in sexual desire, mood, lean body mass and bone density sustained in 3-1/2 year study

Long-term use of AndroGel® (testosterone gel 1% CIII) is safe and effective for men with hypogonadism, a condition sometimes referred to as low testosterone, according to a new study published today in the May issue of the Journal of Clinical Endocrinology & Metabolism. The study, the first to examine safety and efficacy of testosterone gel up to 42 months, was conducted at multiple research centers in the U.S. under the direction of investigators at the Research and Education Institute (REI) at Harbor-UCLA Medical Center. Dr. Christina Wang was the lead author.

With continuous AndroGel® treatment, men in the study experienced rapid and sustained improvements in sexual function and mood. Decreases in fat mass and increases in lean body mass were persistent with treatment. Additionally, gradual and progressive increases in bone mineral density were seen in the spine and hip.

"This AndroGel® study is the first to show long-term benefits and safety with testosterone gel – that’s great news for men suffering from low testosterone," said Ronald Swerdloff, MD, REI Investigator in the Division of Endocrinology, Metabolism & Nutrition, Harbor-UCLA General Clinical Research Center. "This study shows 3+ years of continued benefits and provides new information on the degree of safety for men treated with testosterone. Nevertheless, doctors must monitor their patients throughout therapy."

It is estimated that four to five million American men have low testosterone. It also is 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. Studies show that men lose testosterone at a rate of approximately 10 percent each decade after age 30. Symptoms of low testosterone include diminished interest in sex, erectile dysfunction (ED), reduced lean body mass, decreased bone mineral density, depressed mood and fatigue.

Researchers studied 163 hypogonadal men (mean age = 51) who received continuous replacement with testosterone gel for up to 42 months: 70 percent of the patients received testosterone gel for at least 30 months. Patients were treated with one percent testosterone gel (AndroGel®) at 5, 7.5 or 10 g per day. Dosage could be adjusted by the investigator at each study center depending on the patient’s clinical symptoms and serum testosterone levels. All patients had previously participated in a six-month study comparing the efficacy of AndroGel® with a testosterone patch. The six-month study was then extended to allow for 42 months of treatment. Safety data was compiled for all the participants; data analyses for efficacy included 123 subjects. AndroGel® is manufactured by Unimed Pharmaceuticals, Inc., a Solvay Pharmaceuticals, Inc. Company.

The study results showed significant improvements in mood and sexual performance, motivation and activity soon after initiating testosterone replacement. These improvements were maintained throughout treatment. Lean body mass increased (average of about 3 kg or 6.6 pounds) as early as three months after beginning treatment and was sustained with continuous treatment. Additionally, an increase in muscle strength associated with the increase in lean mass was reported. Bone mineral density (BMD) increased by 0.76, 1.47 and 1.60 percent at the hip and 0.99, 3.10 and 3.80 percent at the spine after 6, 18 and 30 months of treatment. Hematocrit and hemoglobin levels increased as anticipated with androgen replacement, but the increase reached the maximum level at six to 12 months with no further increases with continued testosterone gel treatment. Prostate disease was seen in six patients. Skin irritability was reported as minimal and caused discontinuation in only one patient. Investigators recommend monitoring serum PSA levels and conducting a digital rectal examination in patients prior to initiating therapy and periodically throughout treatment.

In April, Dr. Swerdloff received the Distinguished Andrologist Award from the American Society of Andrologists (ASA) for his outstanding contributions to the progress of andrology.


The Research & Education Institute at Harbor-UCLA Medical Center is one of the largest independent, not-for-profit biomedical research institutes in Los Angeles County. Affiliated with both the David Geffen School of Medicine at UCLA and the Harbor-UCLA Medical Center, the Institute has an annual budget of over $65 million and currently supports more than 1,000 research studies in areas such as cardiology, emerging infections, cancer, women’s health, reproductive health, vaccine research, respiratory physiology, neonatology, molecular biology, and genetics. REI also plays a pivotal role in the training of young physician – scientists and scientists-to-be and is active in promoting the health and well being of nearby communities through community service programs that meet a variety of social and medical needs

David Feuerherd | EurekAlert!
Further information:
http://www.rei.edu/

More articles from Studies and Analyses:

nachricht Innovative genetic tests for children with developmental disorders and epilepsy
11.07.2018 | Christian-Albrechts-Universität zu Kiel

nachricht Oxygen loss in the coastal Baltic Sea is “unprecedentedly severe”
05.07.2018 | European Geosciences Union

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

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

Im Focus: First evidence on the source of extragalactic particles

For the first time ever, scientists have determined the cosmic origin of highest-energy neutrinos. A research group led by IceCube scientist Elisa Resconi, spokesperson of the Collaborative Research Center SFB1258 at the Technical University of Munich (TUM), provides an important piece of evidence that the particles detected by the IceCube neutrino telescope at the South Pole originate from a galaxy four billion light-years away from Earth.

To rule out other origins with certainty, the team led by neutrino physicist Elisa Resconi from the Technical University of Munich and multi-wavelength...

Im Focus: Magnetic vortices: Two independent magnetic skyrmion phases discovered in a single material

For the first time a team of researchers have discovered two different phases of magnetic skyrmions in a single material. Physicists of the Technical Universities of Munich and Dresden and the University of Cologne can now better study and understand the properties of these magnetic structures, which are important for both basic research and applications.

Whirlpools are an everyday experience in a bath tub: When the water is drained a circular vortex is formed. Typically, such whirls are rather stable. Similar...

Im Focus: Breaking the bond: To take part or not?

Physicists working with Roland Wester at the University of Innsbruck have investigated if and how chemical reactions can be influenced by targeted vibrational excitation of the reactants. They were able to demonstrate that excitation with a laser beam does not affect the efficiency of a chemical exchange reaction and that the excited molecular group acts only as a spectator in the reaction.

A frequently used reaction in organic chemistry is nucleophilic substitution. It plays, for example, an important role in in the synthesis of new chemical...

Im Focus: New 2D Spectroscopy Methods

Optical spectroscopy allows investigating the energy structure and dynamic properties of complex quantum systems. Researchers from the University of Würzburg present two new approaches of coherent two-dimensional spectroscopy.

"Put an excitation into the system and observe how it evolves." According to physicist Professor Tobias Brixner, this is the credo of optical spectroscopy....

Im Focus: Chemical reactions in the light of ultrashort X-ray pulses from free-electron lasers

Ultra-short, high-intensity X-ray flashes open the door to the foundations of chemical reactions. Free-electron lasers generate these kinds of pulses, but there is a catch: the pulses vary in duration and energy. An international research team has now presented a solution: Using a ring of 16 detectors and a circularly polarized laser beam, they can determine both factors with attosecond accuracy.

Free-electron lasers (FELs) generate extremely short and intense X-ray flashes. Researchers can use these flashes to resolve structures with diameters on the...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Leading experts in Diabetes, Metabolism and Biomedical Engineering discuss Precision Medicine

13.07.2018 | Event News

Conference on Laser Polishing – LaP: Fine Tuning for Surfaces

12.07.2018 | Event News

11th European Wood-based Panel Symposium 2018: Meeting point for the wood-based materials industry

03.07.2018 | Event News

 
Latest News

Metal too 'gummy' to cut? Draw on it with a Sharpie or glue stick, science says

19.07.2018 | Materials Sciences

NSF-supported researchers to present new results on hurricanes and other extreme events

19.07.2018 | Earth Sciences

Scientists uncover the role of a protein in production & survival of myelin-forming cells

19.07.2018 | Life Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>