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!
Deep Brain Stimulation Provides Sustained Relief for Severe Depression
19.03.2019 | Universitätsklinikum Freiburg
AI study of risk factors in type 1 diabetes
06.03.2019 | University of Gothenburg
DESY and MPSD scientists create high-order harmonics from solids with controlled polarization states, taking advantage of both crystal symmetry and attosecond electronic dynamics. The newly demonstrated technique might find intriguing applications in petahertz electronics and for spectroscopic studies of novel quantum materials.
The nonlinear process of high-order harmonic generation (HHG) in gases is one of the cornerstones of attosecond science (an attosecond is a billionth of a...
Nano- and microtechnology are promising candidates not only for medical applications such as drug delivery but also for the creation of little robots or flexible integrated sensors. Scientists from the Max Planck Institute for Polymer Research (MPI-P) have created magnetic microparticles, with a newly developed method, that could pave the way for building micro-motors or guiding drugs in the human body to a target, like a tumor. The preparation of such structures as well as their remote-control can be regulated using magnetic fields and therefore can find application in an array of domains.
The magnetic properties of a material control how this material responds to the presence of a magnetic field. Iron oxide is the main component of rust but also...
Due to the special arrangement of its molecules, a new coating made of corn starch is able to repair small scratches by itself through heat: The cross-linking via ring-shaped molecules makes the material mobile, so that it compensates for the scratches and these disappear again.
Superficial micro-scratches on the car body or on other high-gloss surfaces are harmless, but annoying. Especially in the luxury segment such surfaces are...
The Potsdam Echelle Polarimetric and Spectroscopic Instrument (PEPSI) at the Large Binocular Telescope (LBT) in Arizona released its first image of the surface magnetic field of another star. In a paper in the European journal Astronomy & Astrophysics, the PEPSI team presents a Zeeman- Doppler-Image of the surface of the magnetically active star II Pegasi.
A special technique allows astronomers to resolve the surfaces of faraway stars. Those are otherwise only seen as point sources, even in the largest telescopes...
Researchers at Chalmers University of Technology and the University of Gothenburg, Sweden, have proposed a way to create a completely new source of radiation. Ultra-intense light pulses consist of the motion of a single wave and can be described as a tsunami of light. The strong wave can be used to study interactions between matter and light in a unique way. Their research is now published in the scientific journal Physical Review Letters.
"This source of radiation lets us look at reality through a new angle - it is like twisting a mirror and discovering something completely different," says...
11.03.2019 | Event News
01.03.2019 | Event News
28.02.2019 | Event News
22.03.2019 | Life Sciences
22.03.2019 | Life Sciences
22.03.2019 | Information Technology