Symptom-Based Testosterone Therapy in Japanese Men With Late-Onset Hypogonadism Syndrome: A Real-World Single-Arm Study Following the 2022 Guideline.

The most frequent symptoms of late-onset hypogonadism syndrome were depressive mood, loss of energy, and easy fatigue.

• 704 men presenting with late-onset hypogonadism-related symptoms were assessed from 2019 to 2023.
• These symptoms may represent core features of late-onset hypogonadism syndrome.
• Serum testosterone levels and symptom profiles were assessed in all 704 men.

No significant association was found between testosterone levels and symptom severity.

• Assessment included 704 men presenting with late-onset hypogonadism-related symptoms.
• This finding supports a symptom-oriented diagnostic approach rather than relying solely on biochemical evaluation.
• The 2022 revised Japanese clinical practice guidelines recommended more flexible diagnostic criteria emphasizing both clinical symptoms and testosterone levels.

Combination therapy with testosterone replacement therapy and daily phosphodiesterase-5 inhibitors significantly improved symptom scores.

• 227 men received combination therapy with testosterone replacement therapy and daily phosphodiesterase-5 inhibitors.
• Changes in mood, vitality, sexual function, and lower urinary tract symptoms were evaluated using validated questionnaires.
• Combination therapy also significantly improved subjective feelings of vigor, confidence, and masculinity.
• 48.4% of patients reported feeling 'better' or 'much better,' 47.2% reported feeling 'slightly better,' and 4.4% experienced 'no change' or 'worsening.'

Patients with normal testosterone levels showed greater improvement in symptom scores following combination therapy.

• This finding was observed among the 227 patients who received combination therapy.
• The result suggests that symptom-based treatment may be particularly beneficial even in men who would not meet traditional biochemical diagnostic thresholds.
• These findings support the revised Japanese guidelines promoting a symptom-oriented treatment strategy alongside biochemical evaluation.

Recovery of morning erections independently predicted overall improvement in patients receiving combination therapy.

• Morning erection recovery was identified as an independent predictor of overall treatment improvement.
• This finding was derived from the cohort of 227 men receiving testosterone replacement therapy combined with daily phosphodiesterase-5 inhibitors.
• Sexual function was among the outcomes evaluated using validated questionnaires.

The 2022 revision of Japanese clinical practice guidelines for late-onset hypogonadism recommended more flexible diagnostic criteria emphasizing both clinical symptoms and testosterone levels.

• Prior to the 2022 revision, diagnostic criteria were less flexible regarding the role of clinical symptoms.
• The revised guidelines promote a symptom-oriented treatment strategy alongside biochemical evaluation.
• This study was designed to evaluate clinical characteristics and treatment effectiveness following the 2022 guideline revision.