Living with low testosterone (low T)? The ETNA Study is evaluating an oral study medicine (leflutrozole) to see if it may help the body produce more testosterone and improve semen quality in men with low T, including men who may not respond well to currently approved treatments.
If you have low testosterone you are not alone. In the United States, the prevalence of low testosterone is about 21.5% in men from 21 to 39 years old. Symptoms could include decreased sex drive, fatigue, lower muscle strength, or erectile dysfunction. Having low testosterone also reduces the quality of semen: low sperm count, motility (how sperm moves), and abnormal shape, which can affect fertility. The ETNA Study aims to identify a new way of improving semen quality and treating men with low testosterone and infertility.
About Leflutrozole:
The oral study medication works by enabling the body to produce more testosterone, which could be an improvement over existing therapies. Other study medication considerations:
- Once-weekly oral medicine is potentially more convenient than existing options.
- If this trial is successful, it could also lead to new treatment options for male infertility which could avoid putting female partners through the extensive medications and highly invasive procedures (and cost) associated with in vitro fertilization (IVF), Assisted Reproductive Technology (ART). This will be evaluated in future trials.
Participants who qualify may receive:
- Access to an investigational medicine that may help people with low testosterone or those who may not respond well to currently approved treatments
- Specialized medical care and monitoring throughout the study
You will receive a stipend for each completed study visit. This compensation is provided in recognition of your time and the inconvenience involved. You are free to stop participating at any time. If you choose to withdraw, you will still receive compensation for the visits you have already completed. Compensation will be explained at your initial study visit.
You may be able to join if you:
- Are a man from 18 to 49 years old
- Have low testosterone based on study tests
You will need to meet other requirements to join the ETNA Study. Please contact a study center for details.
Please select the study center that is most convenient for you.
After screening to see if the study is a good fit, participants who qualify will be randomly assigned (as if by picking a number from a hat) to 1 of 3 doses of leflutrozole (the oral study medicine) or to a placebo group. A placebo looks just like the study medication but has no active ingredients. There is a 3 in 4 (75%) chance that participants will get the oral study medicine. Both treatments are taken once weekly for 16 weeks.
There will be a total of 10 to 11 visits (7 at study site, and 3 to 4 at a separate laboratory for semen collection).
A clinical research study (also called a trial) is carefully supervised research that is done before an investigational drug becomes available to the public.
- Clinical studies follow certain rules to protect the safety, rights, well-being, and privacy of participants.
- The results help doctors and researchers decide if a medication or product is safe and should be available to patients.
- Studies are the only way to develop new medical treatments to improve patient care.
Frequently asked questions
ETNA Study duration
If you are eligible to participate in the study, this will include:
- Screening: Up to 4 weeks
- Treatment period: 16 weeks
- Follow-up period: 4 weeks
You will receive a phone call 3 months after the end of the study to inquire about potential pregnancy in a female partner.
During a clinical study, you’ll take the study medication. This will be done at scheduled times and may occur only once or multiple times throughout the study, depending on the medication. If you take part, you may also have the following assessments performed to monitor your health: checking vital signs, blood work, physical exams, or other types of tests that are necessary to gather the required information about the study medication. In some studies, you may not receive the study medication but instead receive a placebo. All study volunteers are always closely watched by clinic staff and the medical team to ensure their safety.
Placebo: A placebo looks like the study drug being tested, but it doesn’t have any active ingredients. In placebo-controlled research, one group is given the inactive treatment, while another group is given active treatment. This is the best way to find out if the treatment being tested works better than receiving no treatment at all.
Participation in any clinical study is completely up to you. Your decision to participate—or not participate—in this clinical study will have no effect on the medical care that you receive now or in the future. If you are eligible and choose to participate in the study, you may leave at any time, and for any reason.
You will receive a stipend for each completed study visit. This compensation is provided in recognition of your time and the inconvenience involved. You are free to stop participating at any time. If you choose to withdraw, you will still receive compensation for the visits you have already completed. Compensation will be explained by the study site.
There will be no costs related to trial participation, but there will be compensation for visits. Compensation will be explained by the study site.
There are many reasons to participate in clinical research. For starters, it allows participants to play a more proactive role in their own health by receiving a potential treatment for an ongoing disease or condition. Participants also play an important part in bringing much-needed drugs to patients, benefiting thousands of people with the same disease or condition. In many cases, this can be life-changing. In addition to benefiting others with the disease, participants may be paid for their time and travel expenses.
Every clinical trial must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and are balanced by potential benefits to the study participant. As a volunteer, you have the right to stop taking part and can leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled.
ReproNovo ApS is responsible for conducting this clinical study.
