Would you like to take part in an investigationalstudy for men with low testosterone (hypogonadism)?

We're inviting you to take part in a study for men with low testosterone (hypogonadism) who have a history of heart disease or stroke. The purpose is to compare testosterone replacement therapy with placebo to look at the safety of treatment with testosterone replacement therapy in men who have symptoms of low testosterone (hypogonadism) and who are at increased risk for heart disease or stroke.

In addition to receiving the study care and study medication (either testosterone replacement therapy or placebo) at no cost, you also may be eligible for some compensation for your participation. No health insurance is required.

TRAVERSE is studying the safety of testosterone replacement therapy versus placebo in men with low testosterone (hypogonadism) and a history of heart disease or stroke.

You may be able to take part in the study if:

  • You are a 45-80-year-old male
  • You have low testosterone (hypogonadism), shown by:
    1. low testosterone levels from blood tests
    2. symptoms such as decreased sexual desire, decreased energy/fatigue or low mood
  • You have a history of heart disease or stroke
  • The study staff will also check other requirements to confirm that you qualify
VOLUNTEERS WHO QUALIFY TO TAKE PART IN THE STUDY MIGHT BE ELIGIBLE FOR SOME COMPENSATION FOR THEIR PARTICIPATION.
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About Low Testosterone (Hypogonadism)

Testosterone is a sex hormone produced in the body, primarily produced by men in the testicles. This hormone is responsible for deepening the voice, hair growth, the development of bones and muscles, as well as sperm production.

Testosterone production peaks by early adulthood and tends to slow as a man ages. This can result in:

  • Decreased sexual desire or libido
  • Decreased spontaneous erections (e.g., morning erections)
  • Loss of body (axillary and pubic) hair or reduced shaving
  • Decreased energy or fatigue/feeling tired
  • Low mood or depressed mood
  • Hot flashes

Based on blood tests, a physical examination and a review of symptoms, a doctor will be able to diagnose low testosterone (hypogonadism).1

The TRAVERSE Study is studying testosterone replacement therapy or placebo in men with low testosterone (hypogonadism) who have a history of cardiovascular disease.

Sign Up

What happens if I sign up? We will match you to a research study location in your area that needs volunteers with low testosterone (hypogonadism) and who have a history of heart disease or stroke or notify you when one becomes available. The study team will then contact you and if you qualify you may have the opportunity to participate.


If you think you might like to participate in the TRAVERSE Study or would like more information, please enter your information below so we can contact you about the study. Keep in mind that participation is entirely voluntary. If you do decide to take part in this study, you may change your mind about participating at any time.

About the TRAVERSE Study

TRAVERSE is studying the safety of testosterone replacement therapy (TRT) versus placebo in men with low testosterone (hypogonadism) who have a history of heart disease or stroke.

If you participate in the TRAVERSE study, you may receive either testosterone replacement therapy or placebo, and will receive all study required medical care at no cost to you or your insurance company. You also might be eligible for some compensation for your participation.

The study will include approximately 17 visits to a study clinic in your location and 10 phone calls for approximately 5 years. The study staff will work with you to find convenient times for your visits.

The TRAVERSE Study will enroll about 6,000 participants with low testosterone (hypogonadism) and increased risk of cardiovascular disease at approximately 400 study sites in the United States including Puerto Rico.

Who can take part in the TRAVERSE Study?

You may be able to take part in the study if:

  • You are a 45-80-year-old male
  • You have low testosterone (hypogonadism), shown by:
    1. low testosterone levels from blood tests
    2. symptoms such as decreased sexual desire, decreased energy/fatigue or low mood
  • You have history of heart disease or stroke
  • The study staff will also check other requirements to confirm that you qualify

All study-related care is provided by Physicians.

Frequently Asked Questions

What is a clinical research study?

A clinical research study (also called a clinical trial) is conducted to learn whether a drug, treatment, or method is safe and effective for people who have certain ailments or illnesses. Clinical research studies follow strict scientific standards to ensure they produce the best data available for health care decision making.

The purpose of the TRAVERSE study is to compare testosterone replacement therapy with placebo to look at the safety of treatment with testosterone replacement therapy in men who have symptoms of low testosterone (hypogonadism) and a history of cardiovascular disease.

The results of this study will provide more information about the long-term safety of testosterone replacement therapy in men with low testosterone (hypogonadism) who have a history of cardiovascular disease.

Eligible participants will be randomly assigned (like flipping a coin) to receive either the testosterone replacement therapy (TRT) or placebo. The study is designed in such a way so that participants, the study doctor, and the study staff will not know the study drug assignments. However, in the event of an emergency, this information can be provided.

Participants will apply their study drug once a day for approximately 5 years. Participants will also be asked to visit the study clinic up to 17 times for tests and evaluations, as well as 10 phone calls. Total study participation is approximately 5 years which includes screening for eligibility, treatment, and follow-up.

There is no cost to participate in the TRAVERSE Study. If you qualify, all study-related visits, tests, and study drug (Testosterone Replacement Therapy or placebo) will be provided at no cost. If you decide to take part:

  • You will receive study-related care throughout the study from a team of experienced doctors and nurses; and
  • You will receive the study drug (the testosterone replacement therapy or placebo) and all study-related care will be provided at no cost.

The research team will be able to explain more about what the TRAVERSE Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw from the study at any time without affecting those relationships.

Throughout the study, you will not be able to use other testosterone replacement therapy medication. In the TRAVERSE Study, researchers will evaluate the safety of the testosterone replacement therapy or placebo in men with low testosterone (hypogonadism) who have a history of heart disease or cardiovascular diseases.

We match you to a research center within a close travel distance from your home. If we are not running the study in your area currently, with your permission, we will keep you in our database and reach out once a study site in your area becomes available. If, at any time, you decided you no longer want your information stored, you can opt out and we will delete your details.

The study doctor and staff will handle your personal health information in a confidential manner. Your personal health information includes both your study data and original medical records. To ensure your privacy, your name and other identifying information won’t be attached to any records or samples released for research purposes. Instead, the records and samples will only be identified by a code.