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.
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
- Are there results?
- Not yet: the study is under way
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- GL Pharm Tech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of W2505
- ClinicalTrials.gov ID
- NCT07859202
- Acronym / sponsor ID
- W2505-301
- Conditions
- Erectile Dysfunctions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- GL Pharm Tech CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of W2505.
Detailed description
The purpose of this study is to evaluate the efficacy and safety of W2505 in patients with erectile dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: W2505, Drug: W2505-P2W2505 and W2505-P2, 12 weeks. |
| Placebo Comparator | Placebo comparator | Drug: W2505-P1, Drug: W2505-P2W2505-P1 and W2505-P2, 12 weeks. |
| Active Comparator | Active comparator | Drug: W2505-P1, Drug: W2505-RW2505-P1 and W2505-R, 12 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male aged 19 years or older.
- Capable of completing study diaries and questionnaires independently.
- Signed written informed consent.
- run-in medication compliance ≥ 70%
Key exclusion criteria (3 listed)
- Primary hypoactive sexual desire.
- Erectile dysfunction caused by premature ejaculation or untreated endocrine disorders (e.g., untreated hypogonadism, hyperprolactinemia).
- Other exclusions applied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| W2505PO, Once daily(QD), 12 weeks | Drug | Experimental |
| W2505-P1PO, Once daily(QD), 12 weeks | Drug | Active Comparator, Placebo Comparator |
| W2505-RPO, Once daily(QD), 12 weeks | Drug | Active Comparator |
| W2505-P2PO, Once daily(QD), 12 weeks | Drug | Experimental, Placebo Comparator |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.