A randomized, active-controlled, multicenter, phase 3 clinical trial to evaluate the efficacy and safety of GV1001 in...

To determine and compare the efficacy and safety of GV1001 and 5 mg finasteride for benign prostatic hyperplasia (BPH) patients.

This randomized, active-controlled, multicenter, phase 3 clinical trial enrolled 423 patients aged ≥50 years with a prostate volume (PV) >30 mL. Patients were randomized into Group 1 (GV1001 0.56 mg + finasteride placebo), Group 2 (GV1001 1.12 mg + finasteride placebo), or Group 3 (GV1001 placebo +5 mg finasteride). The patients received the study drug during clinic visits every 2 weeks at weeks 0-22. Changes in the international prostate symptom score (IPSS), PV, maximum urinary flow rate (Qmax), prostate-specific antigen (PSA) level, residual urine volume, testosterone and dihydrotestosterone (DHT) levels, and international index of erectile function (IIEF) were assessed.

We included 408 (96.45%) patients (Group 1, n = 138; Group 2, n = 134; Group 3, n = 136) in full analysis set for primary efficacy evaluations. All groups showed significant decreases and increases in the IPSS and Qmax, respectively (Groups 1, 2, and 3, IPSS: -4.78 ± 6.50, -4.99 ± 6.66, and -5.51 ± 6.42, respectively; P < 0.0001; Qmax: P = 0.0005, P = 0.0039, and P < 0.0001, respectively). PV reductions were observed in Groups 2 and 3 (-0.75 ± 8.21 mL [P = 0.3280] and -2.47 ± 7.92 mL [P = 0.0010], respectively). The PSA and testosterone levels of Group 3 significantly decreased and changed, respectively (-0.90 ± 1.25 ng/mL, P < 0.0001 and P < 0.0001, respectively). No significant differences were observed in the residual urine volume. DHT significantly decreased in all groups (Groups 1, 2, and 3: -71.41 ± 244.06 ng/mL [P = 0.0025], -73.84 ± 249.26 ng/mL [P = 0.0019], and -106.60 ± 178.29 ng/mL [P < 0.0001], respectively). Only Group 3 exhibited a significantly decreased IIEF (-3.06 ± 15.34; P = 0.0323). Acute urinary retention occurred in one patient in Group 2. No patients underwent prostate surgery or minimally invasive procedures during the study.

GV1001 exhibited corresponding efficacy and tolerability, providing evidence of amelioration in urinary symptoms among patients with BPH in comparison to the use of 5 mg finasteride.