Effect of Testosterone Replacement Therapy on Quality of Life and Sexual Function in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency: Results From a Randomized Double-blind Trial.

TRT successfully normalized hormonal parameters after 12 months of treatment in the testosterone group.

• After 12 months of treatment, median luteinizing hormone and median free testosterone were normalized in the testosterone group.
• The study used daily transdermal testosterone at a maximum dose of 40 mg/daily.
• Treatment duration was 12 months, with assessments at baseline, 6 months, 12 months, and 3 months post-treatment.

TRT was not associated with statistically significant improvement in symptoms of anxiety and depression compared to placebo.

• 69 men were randomized 1:1 to TRT or placebo over 12 months.
• Anxiety and depression were assessed using validated questionnaires at baseline, 6 months, 12 months, and 3 months post-treatment.
• No statistically significant difference was found between TRT and placebo groups for anxiety or depression outcomes.

TRT was not associated with statistically significant improvement in sexual function compared to placebo.

• Sexual function was assessed using validated questionnaires at multiple time points.
• Participants were aged 18 to 65 years with mild Leydig cell insufficiency after TC treatment.
• No statistically significant improvement in sexual function was observed in the TRT group compared to placebo after 12 months.

TRT was not associated with statistically significant improvement in fatigue or overall quality of life compared to placebo.

• Fatigue and overall quality of life were assessed using validated questionnaires at baseline, 6 months, 12 months, and 3 months post-treatment.
• No statistically significant difference was found between TRT and placebo groups for fatigue or overall quality of life.
• The lack of improvement persisted across all follow-up time points including 3 months post-treatment.

The study population was defined by mild Leydig cell insufficiency, characterized by elevated luteinizing hormone in combination with borderline low testosterone.

• Mild Leydig cell insufficiency was defined as elevated luteinizing hormone in combination with borderline low testosterone.
• This is distinguished from frank hypogonadism, defined as testosterone levels < -2 SD.
• 69 men aged 18 to 65 years with this condition after TC treatment were enrolled.
• Patients with frank hypogonadism and hypogonadal symptoms would typically initiate TRT, but the role of TRT in mild insufficiency was previously unknown.

The authors concluded that routine TRT in TC survivors with mild Leydig cell insufficiency to improve sexual function and quality of life cannot be generally recommended.

• The findings were based on a randomized double-blind trial of 69 participants.
• The authors noted that findings should preferably be validated in a larger cohort.
• The study addressed a gap in knowledge regarding TC patients who have elevated LH with borderline low testosterone, as opposed to overtly low testosterone.