Low T Pill May Reduce Some Risks of Testosterone Gels: Study

A new testosterone pill is being developed, which the manufacturer suggests may be just as effective as other “Low T” treatments, yet would not carry the same risks as popular gels and creams, which may cause problems for women and children who accidentally come into contact with the medication.

Consultants to Clarus Therapeutics recently revealed the results of phase III clinical trials for Rextoro, a 1% oral testosterone undecanoate medication. Some predict that the pill may become be a preferred method for testosterone replacement therapy (TRT), which is currently available as a topical gel, skin patch, implant pellet and injection.

Clarus Therapeutics indicates that it needs to conduct a Phase IV clinical trial to look at how Rextoro affects HDL cholesterol levels in men. In one of the Phase III clinical trials, men given Rextoro saw a 22% drop in HDL cholesterol, often referred to as “good” cholesterol. However, in another trial, the decrease was only 9%. That compares to a 12% decrease seen among men taking AndroGel, the leading testosterone gel product.

If approved by the FDA, a low T pill could quickly unseat AndroGel as the leading testosterone product in the United States. The pill would be easier to use, would likely provide more consistent dosage, and would significantly reduce the risk of problems associated with accidental testosterone gel exposure for women and children, which can cause unwanted hormonal side effects, including changes in hair growth patterns and puberty.

However, Rextoro is being developed amid mounting concerns about the heart risks with testosterone therapy, following multiple studies that have linked all forms of the drugs to an increase risk of heart attacks, strokes, blood clots and sudden death.

Testosterone Drug Risks

Since 2002, testosterone replacement therapy has grown from a niche treatment to a $2 billion industry. Over the past year, serious questions have emerged about the safety of the medications and how they are prescribed.

In January 2014, a study published in the Journal of Clinical Endocrinology & Metabolism suggested that many low testosterone drug prescriptions are not medically necessary. Researchers found that there has been more testing for low testosterone levels in recent years, as well as an increasing number of men prescribed the drugs when they had normal testosterone levels.

Testosterone drug makers have pursued aggressive direct-to-consumer advertising, which encourages men to ask their doctors questions about the effects of low testosterone. Marketing campaigns have introduced the term “Low T”, which some critics have described as “disease mongering”, encouraging men to seek prescription treatments for the natural effects of decreasing testosterone levels as all men age, which can cause drops in energy levels, decreased libido and other general symptoms experienced by all men at one time or another.

While TRT medications are only approved to treat testosterone deficiencies caused by a medical condition, such as hypogonadism, critics have pointed out that many prescriptions are now given for “lifestyle reasons.”

According to a study published in the medical journal Urology in February, there are a number of problems with low testosterone blood test diagnoses. Researchers found that the blood tests alone are not a good gauge for whether a man is actually suffering from low testosterone, suggesting that inconsistencies in testing methods and difficulty interpreting the results of blood tests may lead to a high rate of inaccuracy.

In some cases, blood tests conducted on the same man on the same day showed testosterone levels varying by as much as 30% between labs. The researchers have found that a number of factors can alter the levels of testosterone temporarily, even whether a man’s favorite sports team won a game the night before could affect the blood tests’ results.

Those studies came in the wake of research that appears to indicate that men may also be facing unnecessary health risks from the side effects of testosterone.

In November 2013, a study published in JAMA suggested that side effects of low T treatments may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

That research was followed by a study published in the medical journal PLOSOne in January 2014, which found that low T drugs may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.

In response to the findings, the FDA launched a safety review of all testosterone replacement therapy on January 31, indicating that it is re-assessing the warnings provided with the medication and whether additional regulatory actions are needed.

While still undergoing clinical trials, it is unclear whether the makers of any new testosterone pill may face problems obtaining approval as a result of the on-going safety review.

Low T Lawsuits

Manufacturers of low testosterone drugs currently on the market are now facing a growing number of product liability lawsuits filed by men throughout the U.S. In recent months, hundreds of AndroGel lawsuits and claims involving other drugs have been brought alleging that important safety information about the heart risks was withheld from consumers and the medical community.

Most of the complaints involve similar allegations, indicating drug makers aggressively promoted low T treatments for use among men who had no real medical need. Plaintiffs indicate that use of testosterone drugs caused them to suffer a heart attack, stroke, deep vein thrombosis, pulmonary embolism or other serious injury, including many wrongful death lawsuits.

As the number of complaints filed in U.S. District Courts nationwide has continued to grow, the U.S. Judicial Panel on Multidistrict Litigation established coordinated pretrial proceedings for the cases last month, centralizing all testosterone litigation before U.S. District Judge U.S. District Judge Matthew Kennelly in the Northern District of Illinois.