Rare diseases
Investigational molecules
Locations
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of testosterone replacement therapy in men who have undergone bariatric surgery, which is a type of surgery to help with weight loss. The study is particularly interested in men with two conditions: obesity and male hypogonadism. Male hypogonadism is a condition where the body does not produce enough testosterone, a hormone important for male development and health. The treatment being tested is called testosterone undecanoate, which is given as a solution for injection known as Nebido. Some participants will receive this treatment, while others will receive a placebo, which looks like the treatment but does not contain the active substance.
The purpose of the study is to explore how testosterone therapy, combined with exercise and diet counseling, affects muscle strength and mass in men who have had bariatric surgery. Participants will be randomly assigned to receive either the testosterone treatment or a placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not influenced by expectations or bias.
Throughout the study, participants will be monitored for changes in muscle strength, body composition, and physical function. This includes tests like measuring muscle strength in different parts of the body and assessing physical performance through activities such as stair climbing. The study will also look at other health indicators, such as glucose metabolism, which is how the body processes sugar, and blood clotting factors. The trial is expected to continue until early 2026, providing valuable insights into the potential benefits of testosterone therapy for men with obesity and low testosterone levels following weight loss surgery.
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
4 criteria
5 criteria
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not recruitingJoining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
is being studied to see if it can help improve muscle strength and mass in men who have low testosterone levels and are undergoing bariatric surgery. This therapy involves giving testosterone to help bring hormone levels back to normal, which might support better muscle health and overall well-being.
is also part of the study. Participants receive guidance on physical activities and healthy eating habits. The goal is to see if combining these lifestyle changes with testosterone therapy can further enhance muscle strength and mass after surgery.
Obesity is a condition characterized by excessive body fat accumulation that may impair health. It is typically measured using the Body Mass Index (BMI), where a BMI of 30 or higher is considered obese. The progression of obesity can lead to increased risk of various health issues, including heart disease, diabetes, and joint problems. It often results from a combination of genetic, behavioral, and environmental factors. Over time, obesity can lead to complications such as metabolic syndrome and increased inflammation in the body. Lifestyle changes, including diet and exercise, are commonly recommended to manage this condition.
Male hypogonadism is a condition where the body does not produce enough testosterone, the hormone responsible for male physical characteristics and reproductive function. It can be caused by problems in the testicles or the pituitary gland that controls them. Symptoms may include reduced libido, fatigue, decreased muscle mass, and mood changes. The condition can develop at any age, but its effects vary depending on when it occurs. In adolescents, it may delay puberty, while in adults, it can lead to infertility and decreased bone density. The progression of hypogonadism can affect overall health and quality of life.
Other trials in this disease – keep exploring while you decide
Belgium
BulgariaBulgaria
Italy
GermanyGermanysourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?
Tell us about your condition – we search every trial in Europe and connect you with the right site.
