The Purpose of This Study is to Evaluate the Efficacy and Safety of W2505.

September 29, 2026 updated by: GL Pharm Tech Corporation

A Prospective, Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of W2505

The purpose of this study is to evaluate the efficacy and safety of W2505.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of W2505 in patients with erectile dysfunction.

Study Type

Interventional

Enrollment (Estimated)

228

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Incheon, South Korea
        • Inha University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male aged 19 years or older.
  • Capable of completing study diaries and questionnaires independently.
  • Signed written informed consent.
  • run-in medication compliance ≥ 70%

Exclusion Criteria:

  • Primary hypoactive sexual desire.
  • Erectile dysfunction caused by premature ejaculation or untreated endocrine disorders (e.g., untreated hypogonadism, hyperprolactinemia).
  • Other exclusions applied.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental

W2505 and W2505-P2, 12 weeks.
Drug: W2505

PO, Once daily(QD), 12 weeks

Drug: W2505-P2

PO, Once daily(QD), 12 weeks
Placebo Comparator: Placebo Comparator

W2505-P1 and W2505-P2, 12 weeks.
Drug: W2505-P2

PO, Once daily(QD), 12 weeks

Drug: W2505-P1

PO, Once daily(QD), 12 weeks
Active Comparator: Active Comparator

W2505-P1 and W2505-R, 12 weeks.
Drug: W2505-P1

PO, Once daily(QD), 12 weeks

Drug: W2505-R

PO, Once daily(QD), 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score
Time Frame: Baseline, Week 12

Change from baseline in the erectile function domain score assessed using the International Index of Erectile Function (IIEF) questionnaire.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GL Pharm Tech Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

September 29, 2026

First Submitted That Met QC Criteria

September 29, 2026

First Posted (Actual)

October 5, 2026

Study Record Updates

Last Update Posted (Actual)

October 5, 2026

Last Update Submitted That Met QC Criteria

September 29, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W2505-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe