Erectile DysfunctionsPhase 3NCT07859202

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

A Phase 3 study testing W2505, W2505-P1 and W2505-R in people with Erectile Dysfunctions, run by GL Pharm Tech Corporation at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

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

Who is it for?: Ages 19 years and older, men only
Conditions the study is for: Erectile Dysfunctions
What is being tested?: W2505, W2505-P1 and W2505-R
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 228 participants
Where: 1 siteSouth Korea
Study dates: Sep 2026to Jul 2027
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

Inha University Hospital
Incheon

Other trials in South Korea

About this study

Official title: 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.

Read the detailed description

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

Conditions: Erectile Dysfunctions
Being tested: W2505, W2505-P1, W2505-R, W2505-P2
Medical subject headings: Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

W2505Drug
PO, Once daily(QD), 12 weeks
W2505-P1Drug
PO, Once daily(QD), 12 weeks
W2505-RDrug
PO, Once daily(QD), 12 weeks
W2505-P2Drug
PO, Once daily(QD), 12 weeks

Study groups in NCT07859202
Study group	Role	What they receive
Experimental	Experimental	W2505 and W2505-P2, 12 weeks. Receives: Drug: W2505; Drug: W2505-P2
Placebo Comparator	Placebo comparator	W2505-P1 and W2505-P2, 12 weeks. Receives: Drug: W2505-P1; Drug: W2505-P2
Active Comparator	Active comparator	W2505-P1 and W2505-R, 12 weeks. Receives: Drug: W2505-P1; Drug: W2505-R

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2026Jul 2027

First posted5 Oct 2026
Study startSep 2026 (estimated)
Primary completionJul 2027 (estimated)
Study completionJul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Erectile DysfunctionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 228 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07859202
Sponsor's protocol ID: W2505-301
Status last verified: Sep 2026
First submitted: 29 Sep 2026
Last updated: 5 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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