22 May Testosterone Studies Identify New Treatment Option
Men with testosterone deficiencies may soon have a new oral treatment option available to them thanks in part to a University of Washington researcher.
Dr. John Amory (pictured), Professor of Internal Medicine and Section Head at the UW Medical Center, has been working on developing an oral testosterone option since receiving an initial grant in 2004. Since then, Dr. Amory has conducted approximately 10 different studies examining potential solutions.
“I first became interested in orally dosing testosterone about 10 years ago when patients kept asking when they were going to be able to be treated for testosterone deficiency with a pill instead of needing weekly injections or daily transdermal gels,” said Dr. Amory. “We were prescribing estrogen and other steroid hormones orally at the time, but there weren’t any safe options available to dose testosterone orally.”
In addition to inconvenience, testosterone gels have a risk of inadvertently transferring to women or children. Gels also do not work well for all men. Further, an oral option is particularly appealing for boys with congenital testosterone deficiency who require treatment to begin puberty.
A critical component of Dr. Amory’s research has been the adult Clinical Research Center (CRC) at the Institute of Translational Health Sciences. This is due to the fact that many of his studies require overnight stays, which his own clinical research facility cannot accommodate.
“Some of these pharmacokinetic studies require lengthy stays in excess of 24 hours,” said Dr. Amory. “I can’t sit by the bedside and monitor patients the entire time, which is why the CRC is perfect for this type of study.”
The nursing staff in the CRC monitors each research participant, inserts intravenous lines, administers testosterone doses, measures testosterone levels over time, and monitors vital signs and assesses the subjects for any adverse reactions. In addition, in longer studies, patients are assessed for pharmacodynamics endpoints such as changes in muscle mass, bone density, and body composition via a Dual X-Ray Absorptiometry machine.
“The research staff in the CRC is really superb. They work closely with the investigational drug pharmacy, make sure paperwork is in place, and that the study is safe for the subjects,” shared Dr. Amory.
Over the course of his studies, Dr. Amory and his team discovered that an oral option for testosterone replacement is possible and, when properly dosed, performs reasonably well. He is currently working with a pharmaceutical company on a Phase III open-label study and hopes that an oral form of testosterone will be available to the public for widespread use within the next one to two years. Once done, he plans to apply lessons learned from these testosterone studies to the development of an oral male contraceptive.
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