Ongoing Clinical Trials for Male Hypogonadism
Currently, there is one ongoing clinical trial investigating testosterone replacement therapy for men with low testosterone levels who are undergoing weight loss surgery. This trial is examining how testosterone treatment, combined with lifestyle changes, may affect muscle strength and body composition following bariatric surgery.
Clinical trial locations
Study on Testosterone Undecanoate for Muscle Strength and Mass in Men with Obesity and Low Testosterone Undergoing Bariatric Surgery
This clinical trial is exploring how testosterone replacement therapy affects men who have undergone bariatric surgery, a type of weight loss surgery. The study focuses specifically on men who have both obesity and male hypogonadism, a condition where the body does not produce enough testosterone.
Who can participate:
- Must be eligible for bariatric surgery according to Danish national criteria, meaning men between 18 and 60 years old with a BMI over 35 along with a specific health condition, or a BMI over 40 with significant health issues
- Must be Caucasian men
- Must have a total testosterone level below 12.0 nmol/l
- Must have no medical reasons that would make testosterone treatment unsafe
Who cannot participate:
- Women cannot participate
- Children and teenagers are not included
- Those not undergoing bariatric surgery
- Men without low testosterone levels
- Those unwilling to follow the exercise and diet counseling provided
What the trial involves:
The study examines the effects of testosterone undecanoate, given as an injection called Nebido. Participants are randomly assigned to receive either the testosterone treatment or a placebo, which looks the same but contains no active ingredient. Neither the participants nor the researchers know who receives which treatment, ensuring unbiased results.
Throughout the study, participants receive regular injections and undergo various assessments to measure muscle strength and body composition. Tests include measuring muscle strength in the shoulders and legs, stair climbing performance, and maximum oxygen uptake during exercise. The trial also monitors how the body processes sugar and assesses blood clotting factors.
All participants receive counseling on diet and exercise to support their overall health. The study aims to determine whether combining testosterone therapy with these lifestyle changes can improve muscle strength and mass after weight loss surgery.
The trial is expected to continue until early 2026 and takes place in Denmark.
Summary
Currently, one clinical trial is actively recruiting participants to study male hypogonadism in the context of bariatric surgery. This trial is located in Denmark and focuses specifically on the intersection of obesity, low testosterone levels, and weight loss surgery outcomes. The study investigates testosterone undecanoate as the primary treatment being tested, combined with lifestyle interventions including exercise and diet counseling. The trial represents an important investigation into how hormone replacement therapy may support men with low testosterone during their recovery from bariatric surgery, with particular attention to preserving or improving muscle strength and body composition during significant weight loss.
