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New Erectile Dysfunction Treatment Cleared for Over-the-Counter U.S. Sales

Eroxon, a topical gel, “helps men get an erection within 10 minutes,” according to Futura Medical, the manufacturer.

By Dani Blum and Alisha Haridasani Gupta

This month, the Food and Drug Administration approved the marketing of a new treatment for erectile dysfunction, a topical gel called Eroxon , meaning it can be sold over the counter in the United States. It is the first topical treatment for the condition to be made available without a prescription.

Futura Medical, the British pharmaceutical company that produces Eroxon, claims the gel “helps men get an erection within 10 minutes ” — faster than current oral options, including Viagra, which can take around 30 minutes to an hour to kick in. But because data from full clinical trials has not been published, it’s unclear how effective Eroxon actually is at helping men initiate and maintain an erection, said Dr. Joshua Halpern, a urologist at Northwestern Medicine.

When the gel will become available in the United States “has yet to be determined,” according to a statement from Futura Medical, though it is already available without a prescription in the United Kingdom and in the European Union. The gel has a cooling and warming effect that stimulates the nerves of the penis, prompting blood to engorge the tissue, said Dr. Arthur Burnett, a professor of urology at Johns Hopkins Medicine who was involved with Futura’s trial of the gel. He called the gel safe and “quite appealing.”

The gel broadens options for men with erectile dysfunction, adding to the array of prescription drugs, surgical treatments and devices on the market. But the gel is still not a cure, said Kenia Pedrosa Nunes, an associate professor at the Florida Institute of Technology who has studied the condition. “We are far away from that,” she said.

And, in contrast, there are only two F.D.A.-approved options for treating low libido in women, said Dr. Jagan Kansal, a urologist and co-founder of the Down There Urology clinics in Chicago. “There’s been such a big focus on erections,” he said, “but we as a sexual medicine society haven’t really focused on the women’s part of it.”

What is erectile dysfunction?

A person’s nerves, blood and brain all play a role in erectile function. Developing and holding an erection “requires an extensive balance, a very unique balance, between your nervous system and your vascular system,” Dr. Nunes said.

Erectile dysfunction is the inability to attain or sustain an erection, and it affects an estimated 30 million men in the United States, according to the Centers for Disease Control and Prevention . Often, the condition stems from a lack of sufficient blood flow inside the penis. It most commonly occurs among men over the age of 40 , and the older men are, the more likely they are to have it.

The severity of erectile dysfunction can depend on how often a man experiences it, Dr. Kansal said. “I’ve got patients who say, ‘I can get an erection 80 percent of the time but sometimes I need help’ — that would be considered mild,” he said. “But if they’re like, ‘I haven’t gotten an erection in 10 years,’ then that’s more severe.” And, he added, mild cases can worsen over time: “I call it a progressive chronic condition.”

What causes erectile dysfunction?

Erectile dysfunction is closely associated with several other health conditions, particularly those that are more prevalent among older men. For example, men with diabetes are three times as likely to have erectile dysfunction, according to the C.D.C. The condition can also result from hypertension and is considered a predictor of cardiovascular disease; it may be the first indication of cardiovascular disease or diabetes in some men.

Other potential causes of erectile dysfunction include cancer treatment, smoking, alcohol consumption and sleep disorders, according to the C.D.C. The condition can also be a side effect of certain medications, including antidepressants and allergy medicine, and some research suggests that it can be linked to cannabis use , though that connection is still being studied.

There is also a psychological component — performance anxiety around sex can make it difficult to achieve or maintain an erection, Dr. Halpern said. Hormones play a role, too, he added, as low testosterone levels are linked with erectile dysfunction.

“All these things can conspire together,” Dr. Halpern said.

What treatment options are available?

Almost all of the F.D.A.-approved medications for erectile dysfunction are designed to increase blood flow to the penis. Viagra contains sildenafil, which relaxes arteries and smooth muscle, and other oral options belong to the same class of medications. But if a patient’s erectile dysfunction worsens over time, the oral medication may stop being as effective, Dr. Kansal said.

There are injections that can be administered directly to the penis, as well as penile implant surgeries. Vacuum devices and intraurethral suppository can also be helpful for some patients, Dr. Halpern said.

Since the condition is linked with other health issues, Dr. Kansal recommends that anyone with erectile dysfunction consult a doctor before trying to address it with the over-the-counter gel once it becomes available.

“Even prescription medication, they’re not fixing the underlying problem of blood flow, they’re kind of just covering it up,” he said.

Dani Blum is a reporter for Well. More about Dani Blum

Alisha Haridasani Gupta is a reporter on the Well desk, focused on women’s health, health inequities and trends in functional medicine and wellness. Previously, she wrote the In Her Words newsletter, covering politics, business, technology, health and culture through the gender lens. More about Alisha Haridasani Gupta

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Clinical Trials for Erectile Dysfunction

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and other components of the National Institutes of Health (NIH) conduct and support research into many diseases and conditions.

What are clinical trials, and are they right for you?

Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Researchers also use clinical trials to look at other aspects of care, such as improving the quality of life for people with chronic illnesses. Find out if clinical trials are right for you .

Watch a video of NIDDK Director Dr. Griffin P. Rodgers explaining the importance of participating in clinical trials.

What clinical trials are open?

Clinical trials that are currently open and are recruiting can be viewed at www.ClinicalTrials.gov .

This content is provided as a service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health. NIDDK translates and disseminates research findings to increase knowledge and understanding about health and disease among patients, health professionals, and the public. Content produced by NIDDK is carefully reviewed by NIDDK scientists and other experts.

The NIDDK would like to thank: Tom Lue, M.D., University of California San Francisco

Clinical Trials

Erectile dysfunction.

Displaying 4 studies

The purpose of this study is to create a penile prosthesis registry to be maintained by Mayo Clinic to greatly enhance the quality of published literature, provide more reliable expectations for patients seeking surgery, allow surgeons to compare their outcomes against national and expert standards, and potentially serve as an FDA-reference standard for seeking new device indications.

The purpose of this study is to assess and evaluate the efficacy of the use of MoreNova shockwave therapy in individuals diagnosed with Erectile Dysfunction (ED) by a change in evidence based imagining via Color Duplex Doppler ultrasound (CDDU), and by patient reported questionnaires.

The purpose of this study is to develop and implement an innovative treatment for erectile dysfunction (ED).

The purpose of this investigation is to develop and maintain a database for patients with PD +/- ED in the five years preceding the introduction of collagenase histolyticum (2008-2013) in comparison to the five years following Xiaflex FDA approval (2013-2018).

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• Erectile dysfunction FAQs

Urologist Tobias Kohler, M.D., answers the most frequently asked questions about erectile dysfunction.

Hi. I'm Dr. Kohler, a urologist at Mayo Clinic. I'm here to answer some of the important questions you may have about erectile dysfunction.

Problems with erectile dysfunction are super common. If you look at the decade of life, that predicts what percent of men will have problems. So, for example, 50% of 50-year-olds, 60% of 60-year-olds, so on and so forth, will have problems with erections. But that does not necessarily mean that as you get older, you have to have problems of the penis. There are plenty of men in their 60s, 70s and 80s and 90s with great sex lives. In other words, if you take great care your penis, your penis will take great care of you.

So the things that you can do to take care of yourself to help with erections include exercising, eating well, including a diet high in fruits and vegetables, having a slimmer waistline, sleeping well, quitting smoking. A lot of these things I mentioned are as powerful as medications in helping with erections and improving your sex life.

The penis and overall health is so strongly connected, it's really important to remember that the penis is one of the most powerful predictors we have, especially in young men, for heart attacks. The blood vessels that feed the penis are relatively small. Blood vessels in the heart and the neck are a little bit bigger. So therefore, the penis can predict heart attacks or strokes years in advance when they may occur.

Yes and no. So when we talk about what truly is a problem with erectile dysfunction, the definition is a problem that lasts greater than three months and is a consistent inability to obtain or maintain an erection adequate for intercourse. So when young men get problems with erections, which is very, very common because it's normal to have bad nights here and there. And so, if it happens occasionally, you don't need to be as worried about that. But if you have consistent problems, you absolutely should and must get checked out by a doctor to figure out what's going on, not only because there are great treatments available, but because we may discover underlying medical problems.

When young men have problems with erections, most of the time it's a confidence issue. And so, there are different ways to deal with that. One way is to give medications to get the confidence back. Another way is to use specialists trained in behavioral techniques to get confidence back, so sexual counselors or therapists can really help with this problem.

Modern day, we have several new, exciting, experimental things, such as shockwave therapy of the penis or platelet-rich plasma or stem cell therapy. These are not ready for prime time, and so you should not, as a patient, have to spend your hard-earned money to see whether or not this works for you. It's better to be part of a clinical trial to see if that works or to go with more traditional therapies at this point.

If you want to be a great partner for your medical team to help solve problems with erections, the number one thing you can do is book an appointment. Just like anything else in life, you have to take the initiative, set up an appointment for your physician, say, "Doc, I have a problem with sex." Never hesitate to ask your medical team any questions or concerns you have. Being informed makes all the difference. Thanks for your time and we wish you well.

For many people, a physical exam and answering questions (medical history) are all that's needed for a doctor to diagnose erectile dysfunction and recommend a treatment. If you have chronic health conditions or your doctor suspects that an underlying condition might be involved, you might need further tests or a consultation with a specialist.

Tests for underlying conditions might include:

• Physical exam. This might include careful examination of your penis and testicles and checking your nerves for sensation.
• Blood tests. A sample of your blood might be sent to a lab to check for signs of heart disease, diabetes, low testosterone levels and other health conditions.
• Urine tests (urinalysis). Like blood tests, urine tests are used to look for signs of diabetes and other underlying health conditions.

Ultrasound. This test is usually performed by a specialist in an office. It involves using a wandlike device (transducer) held over the blood vessels that supply the penis. It creates a video image to let your doctor see if you have blood flow problems.

This test is sometimes done in combination with an injection of medications into the penis to stimulate blood flow and produce an erection.

• Psychological exam. Your doctor might ask questions to screen for depression and other possible psychological causes of erectile dysfunction.
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Our caring team of Mayo Clinic experts can help you with your erectile dysfunction-related health concerns Start Here

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Erectile dysfunction care at Mayo Clinic

The first thing your doctor will do is to make sure you're getting the right treatment for any health conditions that could be causing or worsening your erectile dysfunction.

Depending on the cause and severity of your erectile dysfunction and any underlying health conditions, you might have various treatment options. Your doctor can explain the risks and benefits of each treatment and will consider your preferences. Your partner's preferences also might play a role in your treatment choices.

Oral medications

Oral medications are a successful erectile dysfunction treatment for many men. They include:

• Sildenafil (Viagra)
• Tadalafil (Adcirca, Cialis)
• Vardenafil (Levitra, Staxyn)
• Avanafil (Stendra)

All four medications enhance the effects of nitric oxide — a natural chemical your body produces that relaxes muscles in the penis. This increases blood flow and allows you to get an erection in response to sexual stimulation.

Taking one of these tablets will not automatically produce an erection. Sexual stimulation is needed first to cause the release of nitric oxide from your penile nerves. These medications amplify that signal, allowing normal penile function in some people. Oral erectile dysfunction medications are not aphrodisiacs, will not cause excitement and are not needed in people who get normal erections.

The medications vary in dosage, how long they work and side effects. Possible side effects include flushing, nasal congestion, headache, visual changes, backache and stomach upset.

Your doctor will consider your particular situation to determine which medication might work best. These medications might not treat your erectile dysfunction immediately. You might need to work with your doctor to find the right medication and dosage for you.

Before taking any medication for erectile dysfunction, including over-the-counter supplements and herbal remedies, get your doctor's OK. Medications for erectile dysfunction do not work in everyone and might be less effective in certain conditions, such as after prostate surgery or if you have diabetes. Some medications might also be dangerous if you:

• Take nitrate drugs — commonly prescribed for chest pain (angina) — such as nitroglycerin (Nitro-Dur, Nitrostat, others), isosorbide mononitrate (Monoket) and isosorbide dinitrate (Isordil, Bidil)
• Have heart disease or heart failure
• Have very low blood pressure (hypotension)

Other medications

Other medications for erectile dysfunction include:

Alprostadil self-injection. With this method, you use a fine needle to inject alprostadil (Caverject, Edex) into the base or side of your penis. In some cases, medications generally used for other conditions are used for penile injections on their own or in combination. Examples include alprostadil and phentolamine. Often these combination medications are known as bimix (if two medications are included) or trimix (if three are included).

Each injection is dosed to create an erection lasting no longer than an hour. Because the needle used is very fine, pain from the injection site is usually minor.

Side effects can include mild bleeding from the injection, prolonged erection (priapism) and, rarely, formation of fibrous tissue at the injection site.

Alprostadil urethral suppository. Alprostadil (Muse) intraurethral therapy involves placing a tiny alprostadil suppository inside your penis in the penile urethra. You use a special applicator to insert the suppository into your penile urethra.

The erection usually starts within 10 minutes and, when effective, lasts between 30 and 60 minutes. Side effects can include a burning feeling in the penis, minor bleeding in the urethra and formation of fibrous tissue inside your penis.

• Testosterone replacement. Some people have erectile dysfunction that might be complicated by low levels of the hormone testosterone. In this case, testosterone replacement therapy might be recommended as the first step or given in combination with other therapies.

Penis pumps, surgery and implants

Battery-powered penis pump for erectile dysfunction

A penis pump is used to draw blood into the penis to create an erection. You then place a rubber ring around the base of the penis to maintain the erection.

If medications aren't effective or appropriate in your case, your doctor might recommend a different treatment. Other treatments include:

Penis pumps. A penis pump (vacuum erection device) is a hollow tube with a hand-powered or battery-powered pump. The tube is placed over your penis, and then the pump is used to suck out the air inside the tube. This creates a vacuum that pulls blood into your penis.

Once you get an erection, you slip a tension ring around the base of your penis to hold in the blood and keep it firm. You then remove the vacuum device.

The erection typically lasts long enough for a couple to have sex. You remove the tension ring after intercourse. Bruising of the penis is a possible side effect, and ejaculation will be restricted by the band. Your penis might feel cold to the touch.

If a penis pump is a good treatment choice for you, your doctor might recommend or prescribe a specific model. That way, you can be sure it suits your needs and that it's made by a reputable manufacturer.

Penile implants. This treatment involves surgically placing devices into both sides of the penis. These implants consist of either inflatable or malleable (bendable) rods. Inflatable devices allow you to control when and how long you have an erection. The malleable rods keep your penis firm but bendable.

Penile implants are usually not recommended until other methods have been tried first. Implants have a high degree of satisfaction among those who have tried and failed more-conservative therapies. As with any surgery, there's a risk of complications, such as infection. Penile implant surgery is not recommended if you currently have a urinary tract infection.

Recent studies have found that exercise, especially moderate to vigorous aerobic activity, can improve erectile dysfunction.

Even less strenuous, regular exercise might reduce the risk of erectile dysfunction. Increasing your level of activity might also further reduce your risk.

Discuss an exercise plan with your doctor.

Psychological counseling

If your erectile dysfunction is caused by stress, anxiety or depression — or the condition is creating stress and relationship tension — your doctor might suggest that you, or you and your partner, visit a psychologist or counselor.

• Erectile dysfunction and diabetes
• Erectile dysfunction medications
• Erectile dysfunction: Nonoral treatments
• Acupuncture
• Penile implants

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Lifestyle and home remedies

For many people, erectile dysfunction is caused or worsened by lifestyle choices. Here are some steps that might help:

• If you smoke, quit. If you have trouble quitting, get help. Try nicotine replacement, such as over-the-counter gum or lozenges, or ask your doctor about a prescription medication that can help you quit.
• Lose excess pounds. Being overweight can cause — or worsen — erectile dysfunction.
• Include physical activity in your daily routine. Exercise can help with underlying conditions that play a part in erectile dysfunction in a number of ways, including reducing stress, helping you lose weight and increasing blood flow.
• Get treatment for alcohol or drug problems. Drinking too much or taking certain illegal drugs can worsen erectile dysfunction directly or by causing long-term health problems.
• Work through relationship issues. Consider couples counseling if you're having trouble improving communication with your partner or working through problems on your own.

Alternative medicine

Before using any supplement, check with your doctor to make sure it's safe for you — especially if you have chronic health conditions. Some alternative products that claim to work for erectile dysfunction can be dangerous.

The Food and Drug Administration (FDA) has issued warnings about several types of "herbal viagra" because they contain potentially harmful drugs not listed on the label. The dosages might also be unknown, or they might have been contaminated during formulation.

Some of these drugs can interact with prescription drugs and cause dangerously low blood pressure. These products are especially dangerous for anyone who takes nitrates.

• Erectile dysfunction dietary supplements

Coping and support

Whether the cause is physical, psychological or a combination of both, erectile dysfunction can become a source of mental and emotional stress for you and your partner. Here are some steps you can take:

• Don't assume you have a long-term problem. Don't view occasional erection problems as a reflection on your health or masculinity, and don't automatically expect to have erection trouble again during your next sexual encounter. This can cause anxiety, which might make erectile dysfunction worse.
• Involve your sexual partner. Your partner might see your inability to have an erection as a sign of diminished sexual interest. Your reassurance that this isn't the case can help. Communicate openly and honestly about your condition. Treatment can be more successful for you when you involve your partner.
• Don't ignore stress, anxiety or other mental health concerns. Talk to your doctor or consult a mental health provider to address these issues.

Preparing for your appointment

You're likely to start by seeing your family doctor. Depending on your particular health concerns, you might go directly to a specialist — such as a doctor who specializes in male genital problems (urologist) or a doctor who specializes in the hormonal systems (endocrinologist).

Because appointments can be brief and there's often a lot of ground to cover, it's a good idea to be well prepared. Here's some information to help you get ready and know what to expect from your doctor.

What you can do

Take these steps to prepare for your appointment:

• Ask what you need to do ahead of time. When you make the appointment, be sure to ask if there's anything you need to do in advance. For example, your doctor might ask you not to eat before having a blood test.
• Write down any symptoms you've had, including any that might seem unrelated to erectile dysfunction.
• Write down key personal information, including any major stresses or recent life changes.
• Make a list of all medications, vitamins, herbal remedies and supplements you take.
• Take your partner along, if possible. Your partner can help you remember something that you missed or forgot during the appointment.
• Write down questions to ask your doctor.

For erectile dysfunction, some basic questions to ask your doctor include:

• What's the most likely cause of my erection problems?
• What are other possible causes?
• What kinds of tests do I need?
• Is my erectile dysfunction most likely temporary or chronic?
• What's the best treatment?
• What are the alternatives to the primary approach that you're suggesting?
• How can I best manage other health conditions with my erectile dysfunction?
• Are there any restrictions that I need to follow?
• Should I see a specialist? What will that cost, and will the visit be covered by my insurance?
• If medication is prescribed, is there a generic alternative?
• Are there any brochures or other printed material that I can take home with me? What websites do you recommend?

In addition to your prepared questions, don't hesitate to ask additional questions during your appointment.

What to expect from your doctor

Your doctor is likely to ask you a number of questions. Be prepared for questions such as these:

• What other health concerns or chronic conditions do you have?
• Have you had any other sexual problems?
• Have you had any changes in sexual desire?
• Do you get erections during masturbation, with a partner or while you sleep?
• Are there any problems in your relationship with your sexual partner?
• Does your partner have any sexual problems?
• Are you anxious, depressed or under stress?
• Have you ever been diagnosed with a mental health condition? If so, do you currently take any medications or get psychological counseling (psychotherapy) for it?
• When did you first begin noticing sexual problems?
• Do your erectile problems occur only sometimes, often or all of the time?
• What medications do you take, including any herbal remedies or supplements?
• Do you drink alcohol? If so, how much?
• Do you use any illegal drugs?
• What, if anything, seems to improve your symptoms?
• What, if anything, seems to worsen your symptoms?

Our caring team of Mayo Clinic experts can help you with your health concerns. Visit Mayo Clinic Men's Health to get started.

• AskMayoExpert. Erectile dysfunction (adult). Mayo Clinic; 2019.
• What is erectile dysfunction? Urology Care Foundation. https://www.urologyhealth.org/urologic-conditions/erectile-dysfunction. Accessed Nov. 3, 2019.
• Cunningham GR, et al. Overview of male sexual dysfunction. https://www.uptodate.com/contents/search. Accessed Nov. 3, 2019.
• Erectile dysfunction. National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/urologic-diseases/erectile-dysfunction/all-content. Accessed Nov. 3, 2019.
• Sidawy AN, et al., eds. Erectile dysfunction. In: Rutherford's Vascular Surgery and Endovascular Therapy. 9th ed. Elsevier; 2019. https://www.clinicalkey.com. Accessed Oct. 16, 2019.
• Parkinson's and sex. American Parkinson Disease Association. https://www.apdaparkinson.org/what-is-parkinsons/symptoms/sexual-effects/. Accessed Nov. 3, 2019.
• Rew KT, et al. Erectile dysfunction. American Family Physician. 2016; https://www.aafp.org/afp/2016/1115/p820.html. Accessed Oct. 16, 2019.
• Hidden risks of erectile dysfunction "treatments" sold online. U.S. Food and Drug Administration. https://www.fda.gov/consumers/consumer-updates/hidden-risks-erectile-dysfunction-treatments-sold-online. Accessed Nov. 3, 2019.
• Burnett AL, et al. Erectile dysfunction: AUA guideline. The Journal of Urology. 2018; doi:10.1016/j.juro.2018.05.004.
• Wecker L, et al., eds. Drug therapy for myocardial ischemia and angina pectoris. In: Brody's Human Pharmacology: Mechanism-Based Therapeutics. 6th ed. Elsevier; 2019. https://www.clinicalkey.com. Accessed Oct. 16, 2019.
• Ferri FF. Erectile dysfunction. In: Ferri's Clinical Advisor 2020. Elsevier; 2020. https://www.clinicalkey.com. Accessed Nov. 3, 2019.
• Jensen NA. Allscripts EPSi. Mayo Clinic. Nov. 1, 2021.
• Silva AB, et al. Physical activity and exercise for erectile dysfunction: Systematic review and meta-analysis. British Journal of Sports Medicine. 2017; doi:10.1136/bjsports- 2016-096418 .
• Allen MS. Physical activity as an adjunct treatment for erectile dysfunction. Nature Reviews Urology. 2019; doi:10.1038/s41585-019-0210-6.
• Erectile dysfunction: A sign of heart disease?
• Flaccid and erect penis
• What is erectile dysfunction? A Mayo Clinic expert explains

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Strange & offbeat.

Erectile dysfunction is far more common than many realize. Here's how to treat it.

Few topics are more taboo than erectile dysfunction . Though countless men have experienced the frustration or embarrassment of failing to perform as expected during intercourse, it's not something you're likely to hear many of them publicly own. 

But multiple sexual health experts say erectile dysfunction is nothing to be ashamed of and that acknowledging that it sometimes occurs can be healthy. "One can consider erectile dysfunction to be part of a complex, normal, and stressful life ," says Dr. Paul Turek, a men’s fertility physician and the director of the Turek Clinic in San Francisco. "But believe you me, medical care and lifestyle modifications can lead to impressive improvements in not only erections but lifespan in general."

What is ED? 

Erectile dysfunction, often called ED, "is the inability to initiate or maintain an erection firm enough for penetration," says Dr. Stanton Honig, a urologist and chief of the reproductive and sexual medicine department of urology at Yale University School of Medicine. 

It essentially has two components: getting blood into the penis to initially obtain an erection and keeping blood within the penis to maintain it. "Some men may have problems with one, some men may have problems with the other, and some men have a problem with both," explains Dr. Matt Armstrong, a physician and urologist at Revere Health in Utah.

Men often struggle with penis insecurity But no one wants to talk about it.

There are also different types of ED. Chronic erectile dysfunction, for instance, typically means a person has a blood flow problem or a nerve injury , resulting in ongoing issues, Honig explains. "But a patient who only occasionally has problems with erectile dysfunction, most likely has it on a situation basis, meaning that this is not necessarily a permanent condition but may be driven by stress or anxiety which releases adrenaline that will take an erection away or will not allow appropriate blood flow into the penis." 

In other words, for some men, stress or anxiety is the real - and temporary - cause of the issue, and when the stress is dealt away with, the ED usually goes with it. 

How common is ED?

In fact, when it comes to how common ED is, Turek says that stress-related ED is by far the most frequent contributing factor in young men, "especially young healthy men." In this younger population, ED is even more common than some may realize.  One study  shows that nearly 1 in 5 men ages 18-24 experience some trouble getting or maintaining erections. 

Generally, though, ED is known to worsen with age, "but it really is variable on the patient and their overall health as causes of ED relate to cardiovascular disease , atherosclerosis and diabetes," says Armstrong. 

Exactly how common it is in older age groups varies, but, after factoring in the average results of multiple studies, Turek says the most reliable formula to follow when determining how many men of different ages actually deal with the issue is to take one's age and subtract 10%. "So, about 60% of 70-year-olds will have some form of ED, and 40% of 50-year-olds will and so on," he explains. 

How to treat ED

For any such individuals and their partners, the question becomes how to treat the condition. Fortunately, it's a question that has many worthwhile answers. Before one starts looking into any medical interventions, however, it's important to get to the root of what's causing the problem in the first place and dealing with it there. 

"First-line therapies include lifestyle modifications such as regular exercise, a heart-healthy diet , adequate sleep, avoidance of behaviors such as smoking and alcohol, stress reduction and weight loss," says Dr. Nahid Punjani, a physician and urologist at Mayo Clinic in Arizona. "We also always encourage patients to speak to their partners and have an open dialogue - something sex therapy can help with, if needed." 

After seeking to understand and dealing with the root cause, numerous medical intervention options remain. The most popular choice for most men is taking oral tablets such as sildenafil (Viagra) and tadalafil (Cialis), "which can effectively treat about 65% of cases," says Turek. 

If these fail, other alternatives may be worth considering. Some of these include topical gels , intraurethral suppositories and shockwave therapy , says Armstrong. Vacuum erection devices, or "penis pumps," as they are often called, are another proven option. "Although these are somewhat clunky to use, they do work quite well," says Honig. 

More: Erection shockwave therapy may help with erectile dysfunction, but it's shrouded in shame

Another alternative "involves injecting a medication directly into the side of the penis with a tiny needle that barely hurts," says Honig. "This will work in about 70% men that do not respond to oral medication." 

However, any ED-related medical intervention comes with often minor but sometimes significant side effects one ought to be aware of. This starts with meeting with one's primary care provider, "and being honest, open, and frank in discussing your concerns and questions," offers Armstrong. "Your physician will be more than happy to help you find a solution or a specialist who can help you find an option you are comfortable with."

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7 Things to Know About Erectile Dysfunction

If you or your partner is having problems with erections, you’re not alone! Generally thought to be an issue of the aged, erectile dysfunction (ED) is a common problem that happens to men of all ages. A lot of information can be found on the internet regarding ED, but your health care provider is probably the best source of information and therapy. Here are some important things you should know:

• You are not alone!  ED is a very common issue affecting around 50% of patients 50 years of age or older, but can occur at any age. It can be as a result of an injury or just due to physical changes in your body. It can be a lifelong issue or something that slowly crept up over several years. Whatever the case, treatment options are available!
• It’s probably not all in your head.  ED used to be considered a mental problem, but the truth is, the majority of ED is organic, meaning that it has a physical cause. ED can be caused or worsened by medications, surgery, obesity, smoking, hormonal imbalance and other medical problems, such as diabetes or high blood pressure. Often, it is a combination of factors that lead to problems with erections.
• Sleep, exercise, stress all play a role.  Living a healthy lifestyle can not only increase your energy level, but also your overall sexual well-being. Getting good sleep and regular exercise, as well as managing stress, can actually raise your testosterone, the male sex hormone, and increase your libido, as well as your sexual function. 
• It can be a sign of more serious conditions.  ED is frequently a warning sign of cardiovascular disease. Patients will often experience symptoms of ED two to five years prior to cardiovascular symptoms or events, such as heart attack. In addition, men under 60 who have ED are two times more likely to have coronary artery disease. Talking to your health care provider about ED can prompt early screening for other diseases.
• Never take a friend’s medication.  No matter how safe you think a medication is, serious side effects can result from taking a medication that was not prescribed for you. Talk to your health care provider prior to taking a medication, injection or supplement to improve your erections.
• Getting older does not mean the end of intimacy.  There are many options for treatment of ED and therapy can be tailored to the individual or the couple. Many patients enjoy sex into their 90s and beyond. This is not the end of your sex life!
• Talk to someone who can help!  Your sexual health matters! It’s OK to talk to your health care provider about ED and other sexual issues. Your health care provider has likely heard similar questions before and can help you find effective therapies.
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• Published: 22 May 2024

Prescribing semaglutide for weight loss in non-diabetic, obese patients is associated with an increased risk of erectile dysfunction: a TriNetX database study

• Corey Able 1 ,
• Brian Liao 1 ,
• Gal Saffati   ORCID: orcid.org/0009-0005-3053-5828 2 ,
• Ankith Maremanda 3 ,
• James Applewhite 2 ,
• Ali A. Nasrallah 1 ,
• Joseph Sonstein   ORCID: orcid.org/0000-0003-0360-0522 1 ,
• Laith Alzweri   ORCID: orcid.org/0000-0001-8467-2688 1 &
• Taylor P. Kohn 3  

International Journal of Impotence Research ( 2024 ) Cite this article

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• Reproductive disorders
• Risk factors

Semaglutide was approved in June 2021 for weight loss in non-diabetic, obese patients. While package inserts include sexual dysfunction as a side effect, no study has assessed the degree of this risk. The objective of our study is to assess the risk of developing erectile dysfunction after semaglutide is prescribed for weight loss in obese, non-diabetic men. The TriNetX Research database was used to identify men without a diagnosis of diabetes ages 18 to 50 with BMI > 30 who were prescribed semaglutide after June 1st, 2021. Men were excluded if they had a prior erectile dysfunction diagnosis, any phosphodiesterase-5 inhibitors prescription, intracavernosal injections, penile prosthesis placement, history of testosterone deficiency, testosterone prescription, pelvic radiation, radical prostatectomy, pulmonary hypertension, or were deceased. We further restricted our cohort to non-diabetic, obese men by excluding men with a prior diabetes mellitus diagnosis, a hemoglobin A1c > 6.5%, or having ever received insulin or metformin. Men were then stratified into cohorts of those that did and did not receive a semaglutide prescription. The primary outcome was the risk of new ED diagnosis and/or new prescription of phosphodiesterase type 5 inhibitors at least one month after prescription of semaglutide. The secondary outcome was risk of testosterone deficiency diagnosis. Risk was reported using risk ratios with 95% confidence intervals (95% CI). 3,094 non-diabetic, obese men ages 18–50 who received a prescription of semaglutide were identified and subsequently matched to an equal number cohort of non-diabetic, obese men who never received a prescription of semaglutide. After matching, average age at index prescription for non-diabetic, obese men was 37.8 ± 7.8 and average BMI at index prescription was 38.6 ± 5.6. Non-diabetic men prescribed semaglutide were significantly more likely to develop erectile dysfunction and/or were prescribed phosphodiesterase type 5 inhibitors (1.47% vs 0.32%; RR: 4.5; 95% CI [2.3, 9.0]) and testosterone deficiency (1.53% vs 0.80%; RR: 1.9; 95% CI [1.2, 3.1]) when compared to the control cohort of non-diabetic men who never received a semaglutide prescription.

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Corey Able: Idea generation, data collection, data analysis, manuscript writing, manuscript editing. Brian Liao: Data collection, data analysis, manuscript writing. Gal Saffati: Manuscript writing, manuscript editing. Ankith Maramanda: Manuscript writing, manuscript editing. James Applewhite: Manuscript writing, manuscript editing. Ali A. Nasrallah: Idea generation, manuscript writing, manuscript editing. Joseph Sonstein: Idea refinement, manuscript editing. Laith Alzweri: Idea refinement, manuscript editing. Taylor Kohn: Idea refinement, data analysis, manuscript editing.

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Able, C., Liao, B., Saffati, G. et al. Prescribing semaglutide for weight loss in non-diabetic, obese patients is associated with an increased risk of erectile dysfunction: a TriNetX database study. Int J Impot Res (2024). https://doi.org/10.1038/s41443-024-00895-6

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Relationship Between Age, Comorbidity, and the Prevalence of Erectile Dysfunction

Francesco pellegrino.

a Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA

b Division of Oncology/Unit of Urology, IRCCS San Raffaele Hospital, Urological Research Institute, Milan, Italy

Daniel D. Sjoberg

Nicole e benfante, alberto briganti, francesco montorsi, james a. eastham.

c Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA

John P. Mulhall

Andrew j. vickers.

Author contributions : Francesco Pellegrino had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Acquisition of data : Benfante.

Analysis and interpretation of data : Pellegrino, Sjoberg, Tin, Vickers.

Drafting of the manuscript : Pellegrino, Vickers.

Critical revision of the manuscript for important intellectual content : Briganti, Montorsi, Eastham, Mulhall.

Statistical analysis : Pellegrino, Sjoberg, Tin.

Obtaining funding : Vickers.

Administrative, technical, or material support : None.

Supervision : Vickers.

Other : None.

Associated Data

Background:.

Erectile dysfunction (ED) increases with age. Remarkably, the relationship between age and the risk of ED has only been described in crude categories, such as risk for men aged 50–59 yr, without taking comorbidities into account.

To understand how the risk of patient-reported ED varies according to age and comorbidity status.

Design, setting, and participants:

This cross-sectional study included a cohort of 17 250 patients with prostate cancer who completed the International Index of Erectile Function erectile function domain (IIEF-EF) questionnaire before any prostate treatment.

Outcome measurements and statistical analysis:

We created a logistic regression model to predict the probability of ED using age and comorbidities such as cardiovascular disease, diabetes, and hypertension as predictors. We used age as a nonlinear term to allow a curvilinear relationship between age and ED.

Results and limitations:

The prevalence of patient-reported ED among men without any comorbidities increased from 10% to 79% from the age of 40 and 80 yr. The risk of ED increased sharply with comorbidity: the probability of ED for 50- and 75-yr-old individuals was 20% and 68% for healthy men, but 41% and 85% for those with hypertension, obesity, and diabetes. Men with several comorbidities have the same risk of ED as that of healthy men 15–25 yr older. Limitations include a healthier-than-average patient group and lack of information about some comorbidities and the severity of comorbidities.

Conclusions:

Our results allow us to better understand how the risk of ED changes with age and comorbidities. Further research should evaluate the impact of other risk factors not considered in the present study and should take risk factor severity into account.

Patient summary:

Our study shows how the probability of erectile dysfunction (ED) changes with increasing age, analyzed alone and when taking into account the presence of other risk factors for this condition (eg, diabetes, high blood pressure, and cardiovascular disease). Our results help in better understanding the probability of ED for men with and without comorbidities.

1. Introduction

Erectile dysfunction (ED) is defined as the persistent inability to obtain or maintain an erection that is sufficient to allow satisfactory sexual intercourse [ 1 ]. ED has important implications for the quality of life and psychosocial health of men and their partners [ 2 , 3 ].

Age is a well-known risk factor for ED, and several studies have reported on the prevalence of ED with advancing age [ 2 , 4 – 7 ]. Remarkably, all of these studies reported on ED prevalence using crude categories, such as 10-yr age intervals. This is problematic since there may be important variations within these groups. For instance, 50-yr-old men may not have the same ED risk as 59-yr-old men, but are treated the same in a paper reporting ED among men aged 50–59 yr. Moreover, all the studies used mixed populations of participants both with and without other risk factors for ED, such as obesity, hypertension, and diabetes [ 8 ]. Hence, the risks given reflect the respective combined distribution of comorbidities in the cohorts studied. For example, when the authors of the Cologne study [ 4 ] report an ED prevalence of 34% for men aged 60–69 yr, what they mean is that in any group of 100 men in their 60s with the same distribution of comorbidities as 60-yr-old men in the Cologne study, 34 will have ED. Similarly, the Massachusetts Male Aging Study [ 2 ] reported at least minor ED in 50% of men aged 50–54 yr, but again this is true only for groups of men with a similar level of comorbidity as in that study. In this context, our aim was to understand how the risk of patient-reported ED varies according to age, alone and together with the presence of other risk factors for this condition.

At Memorial Sloan Kettering Cancer Center (MSKCC, New York, NY, USA), sexual status surveys are used as part of routine care in the evaluation of patients with prostate cancer. This provides us with a large database of patients that can be used to describe the prevalence of ED by age with far more granularity on age and comorbidity status than prior studies, permitting us to take into account the effect of comorbidities separately. Because ED is a marker of endothelial dysfunction [ 9 ], our results provide insight into how this varies by age and comorbidities.

2. Patients and methods

2.1. study population.

In this cross-sectional study, after obtaining institutional review board approval (reference 17–629), we used a prospective database of 19 601 patients with a diagnosis of prostate cancer referred to MSKCC between 2007 and 2021 who completed ED questionnaires at their first visit. We excluded patients who had undergone previous prostate cancer therapy or surgery for ED. This resulted in a final population of 17 250 men.

2.2. Erectile function assessment

Erectile function was evaluated in our population using the patient-reported erectile function domain score of the International Index of Erectile Function (IIEF), which comprises questions 1–5 and 15 of the IIEF questionnaire (IIEF-EF) and is routinely used as a standalone instrument for this purpose [ 10 ]. We used the MSKCC modification of the IIEF-EF, which incorporates a wider range of sexual behaviors compared to the original IIEF-EF [ 10 ]. We defined patients affected by ED as those with an IIEF-EF score ≤24 [ 11 ].

2.3. Comorbidity assessment

Age, diabetes, dyslipidemia, hypertension, obesity, cardiovascular disease (CVD), lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH), and depression/anxiety were considered as ED risk factors for the present study. These are some of the ED risk factors reported by the American Urological Association [ 12 ] and European Association of Urology guidelines [ 8 ], and associations between these risk factors and ED have been extensively studied [ 13 – 18 ]. Metabolic syndrome [ 19 ], sleep apnea [ 20 ], and smoking [ 21 ] were not included because of inconsistent clinical recording of these risk factors. All risk factors were obtained from the medical history as documented by the physician who evaluated each patient. Dyslipidemia was defined as elevated total cholesterol, low-density lipoprotein cholesterol, or triglyceride levels, or low levels of high-density lipoprotein cholesterol. We defined patients as having CVD if they had a history of coronary artery disease, other heart diseases (eg, rhythm problems, cardiomyopathy, and heart valve diseases), or vascular disease (eg, peripheral vascular disease, stroke, transient ischemic attack, and carotid stenosis), but excluded hypertension and dyslipidemia, as these were considered separately. All risk factors except for age were considered as dichotomous variables (eg, diabetes: yes vs no).

2.4. Statistical models

To estimate the prevalence of ED due to the selected risk factors in our population, we first evaluated whether or not the association between age and ED risk was linear. We used restricted cubic splines for age with four knots placed at the 5th, 35th, 65th, and 95th percentiles, corresponding to 49.6, 60.2, 66.7, and 76.8 yr [ 22 ]. There was strong evidence of a nonlinear relationship between age and the logarithmic odds of ED ( p < 0.001), and therefore the nonlinear terms were retained. To assess further how we should build our model, we evaluated wherever there was interaction between age and each of the other risk factors. We saw no evidence of interaction, with p ≥ 0.5 for all the risk factors except for diabetes ( p = 0.2) and LUTS/BPH ( p = 0.09). Interaction terms were therefore not considered. The predictors included in the final model were age as a nonlinear term and diabetes, dyslipidemia, hypertension, obesity, CVD, LUTS/BPH, and depression/anxiety as binary terms (yes vs no).

To investigate how ED varies according to age and the presence of other risk factors, we converted the coefficient for each risk factor from the multivariable logistic regression model to an integer score; Supplementary Tables 1 and 2 provide further details [ 23 ]. Then we plotted ED prevalence against age and the aggregate risk score obtained by summing the risk factor scores for each combination of possible comorbidities using two different methods. First, we used a line plot representing ED risk by age for men with different aggregate scores (0 = absence of risk factors; 10 = patients with, eg, LUTS/BPH and CVD; 20 = patients with, eg, LUTS/BPH, CVD, hypertension, and obesity; 30 = patients with, eg, depression/anxiety, diabetes, and CVD; and 45 = patients with all six risk factors). Second, we used a heatmap to represent ED prevalence by age and risk factors in a more granular way. As some urologists use an IIEF-EF score <26 to define ED [ 24 ], we repeated all of the analyses using this cutoff. Finally, we plotted the prevalence of moderate ED (IIEF-EF score <17) and severe ED (IIEF-EF score <11) using the same approach. All tests were two-sided with a significance level of 0.05. Statistical analyses were performed using R v4.0.2 statistical software (R Foundation for Statical Computing, Vienna, Austria).

The cohort characteristics are summarized in Table 1 . Approximately half of the study population was affected by ED (51%). All comorbidity risk factors were more frequent in the group of patients with ED, and approximately two-thirds of the men with ED had at least two concomitant risk factors.

Table 1 –

Population characteristics of 17 250 patients stratified by ED (IIEF-EF score ≤24)

ED = erectile dysfunction; IIEF-EF = International Index of Erectile Function erectile function domain.

The multivariable logistic regression results are presented in Table 2 . The intercept for our model was zero. All of the risk factors except for dyslipidemia were significantly associated with ED. Diabetes emerged as the strongest risk factor for ED (odds radio 2.01, 95% confidence interval 1.81–2.24). To ease interpretation, we converted the coefficients from the multivariable model to integer scores using the standard approach of dividing by the smallest coefficient [ 23 ]. We then multiplied by a factor of three and rounded the results to integer numbers ( Supplementary Table 1 ).

Table 2 –

Multivariable logistic regression analysis for erectile dysfunction (International Index of Erectile Function erectile function score ≤24) a

CI = confidence interval.

The prevalence of ED by age and aggregate risk factor scores is shown in Figures 1 and ​ and2 2 for specific combinations of age and comorbidities. The data can also be serve as a visualization of endothelial function in aging males.

Prevalence of erectile dysfunction (ED; International Index of Erectile Function erectile function domain score ≤24) by age for patients with different aggregate risk scores (0, 10, 20, 30, and 45). To obtain the aggregate score for a patient with specific risk factors, add the risk factor scores in the table.

CVD = cardiovascular disease; LUTS/BPH = lower urinary tract symptoms/benign prostatic hyperplasia.

Prevalence of erectile dysfunction (ED; International Index of Erectile Function erectile function domain score ≤24) by age and aggregate risk factor score. Black curves denote ED risk (from 10% to 90%). To obtain the aggregate score for a patient with specific risk factors, add the risk factor scores in the table.

Aggregate risk scores calculated by summing the risk factor scores were used to plot the prevalence of ED for specific combinations of age and various comorbidities. ED prevalence ranged between 10% and 78% for men without comorbidities as age increased from 40 to 80 yr ( Fig. 1 ). At a specific patient age, ED risk greatly increases with the presence of additional risk factors. However, a given relative increase in the odds of ED has differential effects on the absolute risk, depending on the baseline risk. Hence, the effect of comorbidities on the absolute risk of ED was higher for young patients than for older patients. For instance, for a 40-yr-old man the risk of ED increases from 10% to 44% (an increase of 34%) if all the risk factors are present, whereas for an 80-yr-old patient this increase is approximately 18% (from 78% to 96%). The prevalence of ED for 50-yr-old and 75 yr-old men was 20% and 68%, respectively, for healthy men, but 41% and 85%, respectively, for men with concomitant hypertension, obesity, and diabetes. Finally, the data show that healthy older men have the same risk of ED as younger patients who have several comorbidities. For instance, a 50-yr-old man with diabetes, obesity, and hypertension has the same risk of ED as a 65-yr-old man without comorbidities.

Supplementary Table 2 presents the formulae for calculating ED risk for a man with a particular age and risk factor combination. Supplementary Table 3 shows how to calculate risks for different combinations of age and comorbidities. Supplementary Tables 4 and 5 and Supplementary Figures 1 and 2 show results when using an IIEF-EF score <26 as the alternative definition of ED. The results for moderate and severe ED are given in Supplementary Figures 3 and 4 , respectively. It is evident that the shapes of the curves are very similar, albeit with lower prevalence.

4. Discussion

We used a large database to estimate the prevalence of patient-reported ED for specific ages and combinations of comorbid conditions. A particular advantage of our approach is that we provide estimates for men at specific ages rather than for men in 5–10-yr age intervals. This contrasts with previous studies on age and ED [ 2 , 4 – 7 ]. By categorizing age in 5–10-yr ranges, authors overestimate ED risk for younger men and underestimate it for older men in each group. For example, the average risk of ED among healthy men aged 50–59 yr in our study was ~28%, but this varied over an approximately 1.75-fold range, from 20% risk at age 50 yr to 35% risk at age 59 yr.

A second advantage of our approach is that we provide estimates for specific combinations of comorbidities rather than for men with the average comorbidity. Prior studies that explored the relationship between age and ED [ 2 , 4 , 5 , 7 ] reported ED risk for mixed cohorts of patients both with and without comorbidities (eg, hypertension, cardiovascular disease, diabetes). Their results therefore correspond to the average ED prevalence in the general population and not to the ED risk due to age alone. Comparison of ED prevalence between studies is difficult owing to differences in study design, ED definitions, and the methods used to diagnose ED. However, the Massachusetts Male Aging Study [ 2 ] provides an opportunity to compare the methodological approaches. The authors of the Massachusetts study reported ED prevalence of 70% for 70-yr-old men, whereas we found that risk varies from 55% for healthy men to >80% for men with numerous comorbidities.

Our more granular approach allows a better understanding of how ED, and hence endothelial dysfunction in general, changes in the aging male. Previous analyses hypothesized that ED is a harbinger of CVD, suggesting that ED pathology may be the first manifestation of endothelial dysfunction [ 9 , 13 , 25 , 26 ].

We were able to find only one study that reported the prevalence of ED among men without concomitant diseases. Nicolosi et al [ 6 ] interviewed 2412 men across four countries (Brazil, Italy, Japan, and Malaysia) and reported results comparable to ours (eg, ED prevalence of 7.8% for healthy men aged 40–44 yr). However, their study had two main limitations. They reported probabilities for age groups comprising 5-yr increments. Furthermore, in contrast to our use of the validated IIEF-EF instrument, the authors assessed erectile function using the response to a single question (“How would you describe yourself?”) with four possible answers (“always, usually, sometimes or never able to get and keep an erection good enough for sexual intercourse”), which is not validated.

Numerous other studies have shown an association between ED and the comorbidities considered here [ 13 – 18 ]. Nevertheless, our study is the first to estimate the prevalence of ED in the presence of specific comorbidities. However, we evaluated only some of the risk factors associated with ED, and therefore further studies should assess the degree to which other risk factors such as cigarette smoking [ 21 ], metabolic syndrome [ 19 ], and obstructive sleep apnea [ 20 ] are independently associated with ED.

The population in our study presents a potential limitation. We evaluated patients with prostate cancer before they received definitive therapy. Cancer screening, as reported in a recent study [ 27 ], is associated with a lower hazard of all-cause mortality after accounting for other risk factors. The most convincing explanation for this effect is that nonadherence to protocol screening could be a marker for a general behavioral profile involving an unhealthy lifestyle and nonadherence to medical tests and treatments, and consequently a higher risk of mortality; moreover, patients who have short life expectancy because of other diseases should not be screened nor present for treatment of prostate cancer [ 28 ]. We previously showed that patients who undergo radical prostatectomy have life expectancy equivalent to that for men from the general population who are 3 yr younger [ 29 ]. Correcting for this effect would shift the curves in Figure 1 to the left: for instance, a 60-yr-old man with obesity and hypertension (aggregate score 10) would have ED risk of 50% rather than the 44% calculated with the original model. Supplementary Table 6 reports the risk of ED by age according to this correction. Nevertheless, further studies should confirm our findings in a population of patients without prostate cancer.

Another potential limitation of this study is that we included comorbidities in our model as binary variables (eg, hypertension yes vs no) obtained from the patient’s medical history and not defined using predefined cutoffs. Moreover, patients with uncontrolled comorbidities were not distinguished from those with comorbidities well controlled with specific therapies. Finally, we did not consider the risk factor duration. However, all of these pathologies have different severity levels. It is likely, for example, that the risk of ED is very different between men with severe and mild cases of hypertension, ands between men with controlled and uncontrolled hypertension and patients affected by hypertension for a different length of time. Similarly, dyslipidemia, which was not associated with ED in our analyses despite being a well-known risk factor [ 2 , 19 ], would probably emerge as a predictor if lipid status was used as a continuous variable instead of a categorical classification. There is room for future studies to further refine our approach by considering the severity of comorbidities and their treatments.

5. Conclusions

Our results allow a better understanding of how the risk of ED, and endothelial function in general, changes with age and comorbidities. Further research should evaluate the impact of other risk factors not considered in the present study and take risk factor severity into account.

Supplementary Material

Acknowledgments:.

We thank Dr. David Kent for providing comments on an early version of this paper.

Funding/Support and role of the sponsor : This work was supported in part by the National Institutes of Health/National Cancer Institute via a Cancer Center Support Grant to Memorial Sloan Kettering Cancer Center (P30 CA008748), a SPORE grant in Prostate Cancer to H. Scher (P50-CA92629), and the Sidney Kimmel Center for Prostate and Urologic Cancers. The sponsors played no direct role in the study.

Financial disclosures: Francesco Pellegrino certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Andrew J. Vickers is named on a patent for a statistical method for detecting prostate cancer that has been commercialized by OPKO Health as the 4Kscore, and receives royalties from sales of the test and has stock options in OPKO Health.