A Prospective, Randomized Controlled Clinical Trial of Finasteride Combined with Testosterone Undecanoate and Anastrozole in the Treatment of Benign Prostatic Hyperplasia

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600123281

Enrollment

Unknown

Registered

2026-04-23

Start date

2025-11-18

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Benign prostatic hyperplasia

Interventions

Combination therapy group:Combination therapy with testosterone undecanoate, finasteride, and anastrozole

Standard treatment group:Monotherapy with finasteride

Eligibility

Sex/Gender

Male

Age

45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male patients aged 45 to 75 years with a confirmed diagnosis of benign prostatic hyperplasia (BPH); 2. Completion of International Prostate Symptom Score (IPSS) assessment and urinary tract ultrasonography; 3. Completion of serum prostate-specific antigen (PSA) testing and baseline biochemical examinations; 4. Provision of written informed consent and willingness to participate in follow-up.

Exclusion criteria

Exclusion criteria: 1. PSA > 4 ng/mL with pathologically confirmed or suspected prostate cancer by biopsy; 2. Presence of other urological diseases, including prostatitis, epididymitis, orchitis, testicular tumor, testicular tuberculosis, testicular trauma, testicular absence, cryptorchidism, urethral stricture, urinary tract infection, malignant tumor, or neurogenic bladder; 3. History of prostate surgery or minimally invasive therapy (e.g., transurethral resection of the prostate [TURP], prostatic artery embolization [PAE], etc.); 4. Current or recent use of 5a-reductase inhibitors, antiandrogens, estrogens, phosphodiesterase type 5 (PDE-5) inhibitors, or androgen replacement therapy.

Design outcomes

Primary

Measure	Time frame
Total Prostate Volume (TPV);International Prostate Symptom Score (IPSS);Maximum Urinary Flow Rate (Qmax);Post-Void Residual Urine Volume (RUV);	—

Secondary

Measure	Time frame
Serum Total Testosterone (tT);Serum Free Testosterone (fT);Estradiol (E2);Progesterone (P);Prolactin (PRL);Sex Hormone–Binding Globulin (SHBG);Dihydrotestosterone (DHT);C-Reactive Protein (CRP);Prostate-Specific Antigen (PSA);Testosterone-to-Estradiol Ratio (T/E ratio);Libido;Sexual Function;Energy;	—

Countries

China

Contacts

Public ContactZongping Chen

Affiliated hospital of Zunyi Medical University

2404259310@qq.com+86 135 0851 2561

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026