Testosterone is a male sex hormone produced in the testes and adrenal glands. It is responsible for development of male sexual characteristics, such as a deep voice and body hair. Testosterone levels spike during puberty and then gradually decline after age 30, causing low sex drive and erectile dysfunction in some men. Companies market several products to replace or boost testosterone, including patches, gels and injections. Men may also turn to less popular creams, nasal gels, capsules and tablets. Though administered differently, each testosterone product carries risks. It is important for men to understand these products and weigh the risks and benefits before beginning treatment.
Testosterone gels enjoy the status as some of the most popular new products in terms of sales. These prescription drugs come in packets or pumps.
FDA-approved testosterone gels include:
Depending on the brand of medication, men (and some women) apply gels to arms, armpits, abdomen or the inside of the thigh.
AndroGel is one of the most-used medical products to treat Low T. The blockbuster gel is prescribed as a testosterone-replacement drug, mostly to men whose bodies fail to produce sufficient amounts of the male hormone.
The drug was developed by Brussels-based pharmaceutical company Solvay Pharmaceuticals, and the U.S. Food and Drug Administration (FDA) approved it in 2000 for use by men diagnosed with hypogonadism, a drastic decline in testosterone level due to injury or disease.
Abbott Laboratories, AbbVie’s parent company, bought the drug from Solvay in 2010 and soon began pumping millions into the drug’s marketing. Within two years, doctors sounded alerts about the drug’s dangerous side effects for older users — after many men gained prescriptions as a way to regain their youth or simply boost energy and sex drive.
“The market for testosterone gels evolved because there is an appetite among men and because there is advertising. The problem is that no one has proved that it works, and we don’t know the risks.”
- Dr. Joel Finkelstein, an associate professor at Harvard Medical School
One of the biggest risks with AndroGel and other testosterone products is an increase in risk of heart attacks and strokes. The makers of AndroGel now face a growing number of lawsuits filed by men who suffered strokes, heart attacks and blood clots after using the drug. The lawsuits state Abbott and AbbVie failed to warn consumers about these risks.
AbbVie spent nearly $80 million on aggressive marketing campaigns in 2012, and the gel generated over $1 billion in sales that year. AndroGel is the top-selling testosterone product in the U.S. AbbVie markets it in the U.S., while Abbott markets it overseas.
What Is AndroGel and How Does it Work?
AndroGel is synthetic testosterone mixed into a gel with alcohol that is applied to the skin once daily. The testosterone is absorbed into the skin for continuous 24-hour delivery into the body. The medication can cost as much as $500 a month, but some insurance companies cover it.
The drug is available in two strengths: 1 percent and 1.62 percent. Patients dispense the gel through a multi-dose pump or use single-dose packets. It is quick-drying, clear and odorless when dry.
The two dose strengths have different application sites. Patients can apply the 1-percent gel to the upper arms and shoulders as well as on both sides of the abdomen. For the 1.62-percent gel, the gel should only be applied to the upper arms and shoulders.
In men with Low T, the medication is intended to increase the total amount of circulating testosterone in the body to a normal range found in healthy men. According to the drug insert, this measurement is somewhere between 298 – 1043 ng/dl (nanograms per deciliter). If men use lotion or sunscreen, the amount of testosterone absorbed increases.
After applying AndroGel, men should wash their hands thoroughly with soap and water. It is also important to know that the drug is flammable until dry, and patients should avoid flames, smoking or fire.
In men, testosterone gels may decrease sperm count and increase the risk of prostate cancer. Women and children should not come in contact with gels because they can cause serious side effects, including mood swings, skin conditions and diarrhea. These drugs can also harm unborn babies.
Testosterone also comes in an injectable liquid form. Like gels, these drugs help men who no longer produce enough testosterone, but they are also prescribed to stimulate puberty in young men with a delayed onset of adulthood. Some women take them to treat certain types of breast cancer. One type of injectable, Testopel, is a pellet injected into the skin.
Doctors typically give injections in their clinics. Historically, these kinds of supplements were also the most abused.
Popular brands of testosterone injections include:
- Depo-Testosterone (testosterone cypionate)
- Delatestryl (testosterone enanthate)
- Aveed (testosterone undecanoate)
- Testopel (testosterone pellet)
- Ditate-DS (testosterone enanthate)
- Depo-Testadiol (estradiol cypionate; testosterone cypionate)
One of the older drugs of its kind on the market, Depo-Testosterone is an injectable hormone (androgen) replacement used to treat men diagnosed with Low T. Pfizer’s unit Pharmacia & Upjohn Co. currently markets the medication.
The FDA originally approved this drug in 1979 to treat men whose bodies do not make enough testosterone naturally. This is what most doctors prescribe the medication for, but patients sometimes use it to enhance muscle growth and athletic performance — medically unapproved uses.
While lack of testosterone can be dangerous for men, having too much can also be deadly. The dangers of androgen therapy drugs include cardiovascular problems such as heart attack and stroke, and studies also point to an increased risk of prostate cancer.
Depo-Testosterone continues to sell and make money for Pfizer. In recent years it enjoyed a resurgence in popularity.
The latest Low T craze, fueled by multi-million dollar ad campaigns launched by major drug companies, pushed the testosterone market to around $2 billion in annual sales. Prescriptions for these drugs increased, and concerned doctors now warn that many men may simply be using the drug to regain lost youth promised to men in pharmaceutical commercials.
About Depo-Testosterone and Its Use
Unlike AndroGel, the most popular testosterone drug on the market, Depo-Testosterone is not a topical gel. Instead, it is a liquid and is designed for injection into the muscle. The active ingredient, testosterone cypionate, is a white or creamy white powder mixed in with other ingredients to make a solution. The drug is available in two strengths, 100 mg and 200 mg.
Each bottle contains:
- Testosterone cypionate (active ingredient)
- Benzyl benzoate (a chigger, tick and mosquito repellent and fixative used in perfume)
- Cotton seed oil
- Benzyl alcohol (preservative)
Testosterone cypionate dissolved in oil gets injected into the muscle and stays in the body for several days. A patient injects a dose every two to four weeks. Hormones then bind to receptors in the body. The body then expels about 90 percent of the testosterone through urine and feces.
Depo-Testosterone is specifically indicated for use only in men with testicular failure that they were born with or because of a disease, such as prostate cancer. Unfortunately, many Low T clinics provide testosterone to men who are simply getting older and naturally producing less testosterone.
The drug’s label warns against the using it for enhancing athletic performance because of the possible side effects. An ingredient in the solution, benzyl alcohol, is also linked to breathing problems in premature infants.
In the 1990s, the FDA approved two testosterone transdermal patches: Androderm and Testoderm. Testosterone patches are designed to deliver testosterone continuously for 24 hours.
A prescription medicine, patches are indicated to treat men who have low or no testosterone because of certain medical conditions. Patches come in different doses and sizes.
Who Should Not Use Testosterone Patches
Men who have breast cancer or who have or might have prostate cancer should not use testosterone patches. Neither should women who are pregnant or may become pregnant or are breastfeeding. Testosterone patches may harm unborn or breastfeeding babies.
Those considering the use of testosterone patches should first tell their healthcare provider if they have:
- Breast cancer
- Prostate cancer
- Urinary problems due to enlarged prostate
- Kidney or liver problems
- Heart problems
- Sleep apnea
- Other medical conditions
How to Apply Testosterone Patches
Apply the adhesive side of a patch to skin that is clean, dry and not broken. Make sure the patch is pressed firmly in place and that there is good contact with the skin, especially around the edges.
Patches are meant for the back, stomach area, upper arms or thighs, not the scrotum, buttocks or a bony area. Users should avoid areas of skin that are oily, perspire heavily or are covered with hair because the patches may not stick well to these areas, according to the drug’s label.
Every 24 hours, at about the same time each night, remove patches and apply new ones. Rotate the application site every day, and do not use the same site more than once every seven days.
Testosterone patches can cause serious side effects including blood clots in the legs or lungs, enlarged painful breasts, sleep apnea and swelling in the ankles, feet or body, with or without heart failure. They can also increase a user’s risk of prostate cancer, cause more erections than normal or erections that last longer, or in large doses, may lower a user’s sperm count.
Other Testosterone Products
While gel, injections and patches make up the bulk of the current testosterone market, the drugs also come up in creams, nasal gels, capsules and tablets, known as buccal systems. For this drug specifically, buccal systems are applied to the upper gum of the mouth.
Other prescription testosterone products include:
- Oreton (discontinued)
- Methyltestosterone (discontinued)
- Android (discontinued)
Testosterone boosters may contain some combination of the following ingredients:
A precursor hormone that can be converted to testosterone or estrogen in the body, DHEA is often marketed as a means of boosting testosterone and muscle mass. Research on those claims is inconsistent. Side effects may include breast enlargement, cholesterol changes and hair loss.
While there is some evidence that large doses can increase testosterone, taking zinc at doses high enough to be effective can have side effects, including elevated cholesterol, increased prostate cancer risk, and liver or kidney problems.
An amino acid hyped as a testosterone booster, this supplement has little evidence to back its claims and has been associated with side effects that include increased prolactin levels and breast enlargement, bloating, anxiety, headaches and confusion.
Emily Miller holds five Health Literacy certificates from the Centers for Disease Control and Prevention as well as a Bachelor of Science in Journalism from the University of Florida. She is a member of The Alliance of Professional Health Advocates and the American Association for the Advancement of Science. Emily was diagnosed with a chronic illness as a child and has firsthand experience with many of the topics she writes about as a member of the Drugwatch team. She is an award-winning journalist who has reported on health and legal news for reputable organizations, including the South Florida Sun Sentinel, San Antonio Express-News, UF Health News and Reporters Committee for Freedom of the Press. She draws on her background as both a patient and a journalist to help readers understand complex health and legal topics.