Evidence map›Paper›PMID 40620871›Full record

ArticleProstate international2025

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

Teak Jun Shin, Ji Yong Ha, Se Yun Kwon, Dong Jin Park, Jang Hwan Kim, Sung Won Lee, In Gab Jeong, Ji Youl Lee, Tag Keun Yoo, Tae Hyoung Kim and 18 more

Abstract read
In one paragraph

Article in Prostate international, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Teak Jun ShinKeimyung University Dongsan Hospital, Korea.
Ji Yong HaKeimyung University Dongsan Hospital, Korea.
Se Yun KwonDongguk University Gyeongju Hospital, Korea.
Dong Jin ParkDongguk University Gyeongju Hospital, Korea.
Jang Hwan KimSeverance Hospital, Korea.
Sung Won LeeSeoul Samsung Medical Center, Korea.
In Gab JeongSeoul Asan Medical Center, Korea.
Ji Youl LeeThe Catholic University of Korea, Seoul ST. Mary's Hospital, Korea.
Tag Keun YooNowon Eulji Medical Center, Eulji University, Korea.
Tae Hyoung KimChung-Ang University Hospital, Korea.
Du Geon MoonKorea University Guro Hospital, Korea.
Sung Kyu HongSeoul National University Bundang Hospital, Korea.
Jin Seon ChoHallym University Medical Center, Korea.
Hong Sang MoonHanyang University Medical Center, Korea.
Jeong Woo LeeDongguk University Medical Center, Korea.
Seok Joong YunChungbuk National University Hospital, Korea.
Youn Soo JeonSoonchunhyang University Hospital, Korea.
Jong Gwan ParkJeonbuk National University Hospital, Korea.
Taek Won KangChonnam National University Hospital, Korea.
Ki Hak MoonYeungnam University Medical Center, Korea.
Jae Shin ParkDaegu Catholic University Medical Center, Korea.
Yoon Soo HahDaegu Catholic University Medical Center, Korea.
Tae Gyun KwonKyungpook National University Chilgok Hospital, Korea.
Jae Wook ChungKyungpook National University Chilgok Hospital, Korea.
Jae Il ChungInje University Busan Paik Hospital, Korea.
Dong Soo RyuChangwon Samsung Medical Center, Korea.
Sung Woo ParkPusan National University Yangsan Hospital, Korea.
Kyung Seop LeeKeimyung University Dongsan Hospital, Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: To determine and compare the efficacy and safety of GV1001 and 5 mg finasteride for benign prostatic hyperplasia (BPH) patients. Patients and methods: 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. Results: We included 408 (96.45%) patients (Group 1, Conclusions: 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.

Indexed as

Benign prostatic hyperplasiaFinasterideGV1001International prostate symptom scoreProstate volumeRandomized controlled trial

Identifiers

PMID40620871
PMCPMC12223535

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.