A randomized, active-controlled, multicenter, phase 3 clinical trial to evaluate the efficacy and safety of GV1001 in patients with benign prostatic hyperplasia

• Published in: Prostate international 2024-10
• Main Authors: Shin, Teak Jun, Ha, Ji Yong, Kwon, Se Yun, Park, Dong Jin, Kim, Jang Hwan, Lee, Sung Won, Jeong, In Gab, Lee, Ji Youl, Yoo, Tag Keun, Kim, Tae Hyoung, Moon, Du Geon, Hong, Sung Kyu, Cho, Jin Seon, Moon, Hong Sang, Lee, Jeong Woo, Yun, Seok Joong, Jeon, Youn Soo, Park, Jong Gwan, Kang, Taek Won, Moon, Ki Hak, Park, Jae Shin, Hah, Yoon Soo, Kwon, Tae Gyun, Chung, Jae Wook, Chung, Jae Il, Ryu, Dong Soo, Park, Sung Woo, Lee, Kyung Seop
• Format: Article
• Language: English
• Subjects: Benign prostatic hyperplasia; Finasteride; GV1001; International prostate symptom score; Prostate volume; Randomized controlled trial
• ISSN: 2287-8882
• DOI: 10.1016/j.prnil.2024.10.001

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