Efficacy and safety of low-intensity pulsed ultrasound (LIPUS) in treating late-onset hypogonadism

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100045527

Enrollment

Unknown

Registered

2021-04-18

Start date

2021-04-20

Completion date

Unknown

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

late-onset hypogonadism

Interventions

Low energy treatment group A:Treat with low energy, twice/week

Moderate energy treatment group B:Treat with moderate energy, twice/week

Control group:Treat with no energy, twice/week

Eligibility

Sex/Gender

Male

Age

45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.The patient must be able and agreed to sign an informed consent; 2.Aged 45-75 years, male; 3.Serum calculated free testosterone (cFT) < 243 pmol/L (blood collection time 7AM~11AM) (2017 EAU diagnosis and treatment guidelines) or free testosterone index (FTI) < 0.153 nmol/nmol (total testosterone/sex hormone binding globulin ratio ); 4.Screening of male androgen deficiency Assessment (ADAM) questionnaire in middle-aged and elderly men. Questions 1 and 7 or any 3 questions answer "yes".

Exclusion criteria

Exclusion criteria: 1.Prostate-specific antigen (PSA)> 4 ng/ml; 2.Severe lower urinary tract symptoms (LUTS) (International Prostate Symptom Score IPSS>19); 3.Any unstable or uncontrolled chronic diseases, including severe hypertension (systolic blood pressure>=180 mmHg), uncontrolled diabetes, liver and kidney dysfunction, cardiovascular and cerebrovascular diseases, blood system diseases, etc.; 4.Primary hypogonadism (LH and FSH increase), secondary hypogonadism (LH and FSH low); 5.History of mental illness and are receiving psychotropic drug treatment; 6.Acute orchitis epididymitis, scrotal skin infection; 7.Severe varicocele, hydrocele, diseases of the inguinal area such as inguinal hernia; 8.Have taken hormone drugs or other treatment methods in the past 3 months; 9.Those who have participated in any other medical device or drug clinical research in the past 3 months; 10.The investigator deemed that it is not suitable for patients participating in this trial.

Design outcomes

Primary

Measure	Time frame
Free Testosterone;Symptom Rating Scale for Middle-aged and Elderly Men;	—

Secondary

Measure	Time frame
Serum Total Testosterone;Free Testosterone Index;Luteinizing Hormone;Sex Hormone Binding Globulin;International Index of Erectile Function-5;International Prostate Symptom Score;	—

Countries

China

Contacts

Public ContactXia Shujie

Shanghai General Hospital

xsjurologist@163.com+86 13761258811

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026