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Randomized Controlled Study on the Effects of Aromatase Inhibitors on Gonadal Function in Male Obese Patients

Randomized Controlled Study on the Effects of Aromatase Inhibitors on Gonadal Function in Male Obese Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120390
Enrollment
Unknown
Registered
2026-03-13
Start date
2026-03-15
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Secondary hypogonadism in men

Interventions

Group A:Receive standardized lifestyle intervention, including dietary guidance, exercise prescription, and behavioral modification, with pharmacotherapy when necessary, aiming for a 7–10% reduction i
Group B:Receive standardized lifestyle intervention, including dietary guidance, exercise prescription, and behavioral modification, combined with oral letrozole (2.5 mg),Once a week
Group C:Undergo standardized lifestyle intervention combined with oral testosterone undecanoate (40 mg, three times daily).

Sponsors

Anqing First People's Hospital Affiliated to Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Males aged 18–60 years; 2. BMI >=30 kg/m^2, or BMI >=28 kg/m^2 with central obesity; 3. Diagnosis of hypogonadism: at least two morning fasting serum total testosterone measurements < 12 nmol/L; 4. Voluntary participation and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Non-obesity-related hypogonadism; 2. Severe cardiac, hepatic, or renal dysfunction; 3. Prostate cancer or suspected prostate disease; 4. Severe uncontrolled sleep apnea; 5. Current use of medications affecting sex hormone metabolism; 6. Mental disorders or inability to comply with the study procedures.

Design outcomes

Primary

MeasureTime frame
Serum Total Testosterone (TT);Free Testosterone (FT);

Secondary

MeasureTime frame
Estradiol (E2);Luteinizing Hormone (LH);Follicle-Stimulating Hormone (FSH);Sex Hormone-Binding Globulin (SHBG);International Index of Erectile Function Questionnaire (IIEF-5);Aging Males' Symptoms (AMS) Scale;Metabolism and Body Composition, Including Fasting Blood Glucose, Insulin, Lipid Profile (Total Cholesterol, LDL, VLDL, HDL, Triglycerides, and Free Fatty Acids), and Glycated Hemoglobin (HbA1c);General Parameters: Including Blood Pressure, Heart Rate, Body Weight, Body Mass Index (BMI), and Waist Circumference;

Countries

China

Contacts

Public ContactZheng Hailan

Anqing First People's Hospital Affiliated to Anhui Medical University

Lanlan19751@126.com+86 155 5561 6688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026