Treating Low Testosterone in Men
How Low T Medicine Innovations Are Brought to Market
Low testosterone in men, or andropause, can be treated with testosterone replacement. Learn how low T medicines are developed and tested for safety.
By Chris Iliades, MD
Medically Reviewed by Niya Jones, MD, MPH
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A television advertising campaign for testosterone replacement using an underarm applicator has put the idea of low T front and center in the public's mind. However, a lot went on behind the scenes before those ads, and the drug they champion, went live.
Martina M. Cartwright, RD, PhD, a specialist in nutritional science and biomolecular chemistry, was part of the team that brought that drug to market.
“My role was to educate doctors about the drug and to review side effects and safety," Dr. Cartwright said. "There is always tug of war between education and marketing for a new drug. You don’t want to oversell the drug, but you do want men to be aware of low testosterone and the possibility of treatment."
Low testosterone has been called the male menopause, or andropause, when it happens naturally with age. Testosterone, the male hormone, peaks at about age 30 and then goes into gradual decline. For some men, however, low T may come on suddenly because of obesity, diabetes, and a number of other conditions.
An estimated 13 million men 45 and older have symptoms of low T. Because symptoms may include low sex drive, erectile dysfunction, fatigue, and depression, the potential demand for testosterone replacement is big.
Bringing a New Testosterone Drug to Market
“Any new drug launch involves several phases before gaining final approval," Cartwright said. "A new drug may start with animal studies, then move to healthy humans, and then be tested in people who the drug is meant to help. You need to prove that the drug is safe and that it works. That can take an average of 12 to 15 years.”
The clinical trial phases for drug approval include:
- Phase I trials, which test a new drug in a small group of people to determine the safe dose.
- Phase II trials, which use a larger group to evaluate safety and effectiveness.
- Phase III trials, which evaluate the drug’s effectiveness and safety compared with commonly used treatment.
- Phase IV trials, which are done to get more information about a drug once it's been approved by the U.S. Food and Drug Administration (FDA).
“It takes a team of doctors and research scientists to design and launch a new drug," Cartwright said. "Only one out of 20 launches ever results in a new drug to market. At the end of the process, the FDA might approve your drug or send it back for more testing. Once the drug is approved, you need to label the drug with all its possible side effects and market it."
The new underarm drug for low T went through a phase III study at many different study centers. Those trials found that 84 percent of the men in the study, who started with low testosterone, had testosterone levels back in the normal range after 120 days of treatment.
What You Need to Know About Low T Medications
The problem with low T drugs isn't that they don’t work. They do. The problem is figuring out the best way to get them into your system and minimize the side effects they have. When taken in pill form, testosterone can cause liver damage. No oral testosterone medicines are available in the United States.
Commonly available options now are:
- An injection given into a muscle every two to three weeks
- A patch worn on your body every day that you move from place to place
- A gel applied to your shoulders, arms, or belly
- The new underarm applicator
In the underarm testosterone trial, the most common side effects were skin reactions, headaches, vomiting, and diarrhea. Some men also had an increase in their red blood cell counts and an increase in prostate-specific antigen (PSA, a substance in the blood that's used to screen for prostate cancer).
Side effects seen with other testosterone medicines include acne, fluid retention, breast enlargement, sleep disturbance, and loss of testicle size. Also, testosterone replacement is not recommended if you have prostate cancer or male breast cancer. Any men considering testosterone replacement should talk with their doctor about all of these side effects and be aware that medications that are applied to the skin can rub off and cause side effects in women and children who come into contact with them.
Possible New Low T Drugs
A new oral drug is currently in a phase III trial to test for safety and efficacy. This drug is being compared to a gel form of testosterone. Men who volunteer for the study must be 18 to 75 years of age and have low testosterone levels on two blood tests within one week.
Another testosterone medication, one that's applied into the nose as an intranasal spray, might eliminate the complications of skin irritation and rub-off onto others seen with testosterone skin preparations. Its pre-approval trials have been completed.
“These trials and others are given out to clinical trial sites around the country and, increasingly, in other countries," Cartwright said. "The sites are responsible for recruiting the patients, doing the blood tests, and having the men who volunteer fill out data sheets. The pharmaceutical companies send out monitors to check, but they rely on the integrity of the clinical sites. If these sites do sloppy work, unexpected side effects may show up down the road."
Getting any drug, including drugs for low T, safely on the market is a big and expensive job. “The patent for drugs is 20 years," Cartwright said. "It starts as soon as you start the process. Since it may take 15 years to complete, that can leave only five years for the company to make good on its investment. That is why new drugs are expensive."
Cartwright no longer works for the drug manufacturer that developed the underarm low T drug, but she continues to educate and consult through a company she started two years ago called Beacon Science. Her work and the work of many other doctors and researchers is the key to safe and effective treatment of low T and many other conditions.
Video: Treating Low T
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