Testosterone Replacement Therapy (TRT) (Enrolling Trials)

Men: It’s okay to talk about low testosterone (hypogonadism)

Decreased sexual desire?, Feel fatigued?, Depressed mood?; what you’re feeling could be related to low testosteron (hypogonadism).

What is hypogonadism?

Hypogonadism is when the sex glands called the gonads make few, if any, sex hormones. It can affect both adolescents and adults of all genders.

The condition causes a low sex drive or libido. If you want to know more about hypogonadism, we recommend that you go to this post.

Currently for people with hypogonadism, the TRAVERSE study is offered, which is a clinical study investigation that tests a testosterone replacement therapy in men with low testosterone (hypogonadism) and a history or risk of heart disease or stroke.

The TRAVERSE study is enrolling now.

What’s the purpose of the TRAVERSE clinical research study?

A clinical research study 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, also known as clinical trials, follow strict scientific standards to ensure they produce the best data available for health care decision making.

If you want to know more about clinical research, you can go to this link.

Why should I participate?

Your participation in this study could help doctors learn more about a testosterone replacement therapy for men with a history or risk of heart disease or stroke. You’ll also contribute to clinical research and help shape future treatment options.

Some research study volunteers are interested in gaining access to drugs or treatments. Other study volunteers want to help advance science. If you participate in the TRAVERSE study, you may receive either testosterone replacement therapy
or placebo, and will receive all studyrequired medical care.

You also might be eligible for some compensation for participation.

Do I qualify for the TRAVERSE study?

To qualify, you must meet the following requirements:

  • Men 45 to 80 years of age
  • Have a history or risk of heart disease or stroke
  • Have low testosterone (hypogonadism), shown by: testing to measure your testosterone levels, symptoms such as decreased sexual desire, low energy and depressed mood.

The study staff will also check other requirements to confirm that you qualify

What happens during the TRAVERSE study?

Before you agree to join the study, the study doctor will explain the study procedures and answer any questions you might have. To participate, you must read and sign an informed consent document to show that you understand the study and what’s required of you. As the document will explain, you’re free to leave the study at any time.

Next, the study doctor and staff will give you some tests to make sure that you’re eligible to participate. If eligible, you’ll receive testosterone replacement therapy or placebo in the form of a gel that you’ll apply to your skin. Your study participation will last approximately 5 years, and the study staff will work with you to find convenient times for your visits. If you have any questions, be sure to ask the study staff.

What about my private health information?

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.

You can download study brochure (PDF)