Erectile DysfunctionPhase 3NCT07899073
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
A Phase 3 study testing HIP2602 + HPP2602-2, HPP2602-1 + HPP2602-2 and HGP1201 + HPP2602-1 in people with Erectile Dysfunction, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients Read more about this study
- Who is it for?
- Ages 19 to 75 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- HIP2602 + HPP2602-2, HPP2602-1 + HPP2602-2 and HGP1201 + HPP2602-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2026to Sep 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Visit 1 (screening)
- Male subjects aged 19 to 75 years, inclusive.
- Subjects with a history of erectile dysfunction for at least 3 months prior to Visit 1.
- Subjects who are expected to have sexual intercourse with the same adult female partner throughout the study period.
- Subjects who agree to attempt sexual intercourse at least 4 times on 4 separate days during the run-in period.
- Visit 2 (Randomization)
- Subjects with an International Index of Erectile Function (IIEF) Erectile Function (EF) domain score of ≤25 at Visit 2.
- Subjects who attempted sexual intercourse at least 4 times on 4 separate days during the run-in period and demonstrated a sexual intercourse failure rate of ≥50%, as assessed by the Sexual Encounter Profile (SEP).
Who cannot join
- Erectile dysfunction associated with premature ejaculation or endocrine disorders (e.g., hypogonadism, hyperprolactinemia, thyroid disorders)
- Uncontrolled diabetes mellitus (HbA1c > 10% at Visit 1)
- History of radical prostatectomy or other pelvic surgery
- Presence of anatomical penile deformity (e.g., Peyronie's disease, penile angulation, cavernosal fibrosis)
- History of major cardiovascular or cerebrovascular disease, including unstable angina, recent myocardial infarction, stroke, uncontrolled arrhythmia, or heart failure
- History of retinitis pigmentosa, NAION, or other hereditary retinal degenerative disorders
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- Clinically significant hepatic or renal impairment
- Positive serology for infectious diseases at Visit 1
- Prior failure to respond to PDE-5 inhibitor therapy
- Use of prohibited concomitant medications or anticipated need for such medications during the study
- Participation in another clinical trial within 30 days prior to Visit 1
- Known hypersensitivity to the study drug or its components
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hyun Jun Park contact
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Hospital
Busan
Hyun Jun Park, MD., Ph.D, 82-51-240-7347, joon501@naver.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
- Conditions
- Erectile Dysfunction
- Being tested
- HIP2602 + HPP2602-2, HPP2602-1 + HPP2602-2, HGP1201 + HPP2602-1
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP2602 + HPP2602-2Drug
Test drug
HPP2602-1 + HPP2602-2Drug
Control drug
HGP1201 + HPP2602-1Drug
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| HIP2602 + HPP2602-2 | Experimental | Daily administration, oral Receives: Drug: HIP2602 + HPP2602-2 |
| HPP2602-1 + HPP2602-2 | Placebo comparator | Daily administration, oral Receives: Drug: HPP2602-1 + HPP2602-2 |
| HGP1201 + HPP2602-1 | Other | Daily administration, oral Receives: Drug: HGP1201 + HPP2602-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of IIEF-EF domain score from baseline after 12 weeks
Measured: baseline, 12 weeks
Secondary outcomes (10)
Change of IIEF-EF domain score from baseline after 6 weeks
Measured: baseline, 6 weeks
Change of IIEF-OF domain score from baseline after 6, 12 weeks
Measured: baseline, 6 weeks, 12 weeks
Change of IIEF-SD domain score from baseline after 6, 12 weeks
Measured: baseline, 6 weeks, 12 weeks
Change of IIEF-IS domain score from baseline after 6, 12 weeks
Measured: baseline, 6 weeks, 12 weeks
Change of IIEF-OS domain score from baseline after 6, 12 weeks
Measured: baseline, 6 weeks, 12 weeks
Change of IIEF Question 3 score from baseline after 6, 12 weeks
Measured: baseline, 6 weeks, 12 weeks
Change of IIEF Question 4 score from baseline after 6, 12 weeks
Measured: baseline, 6 weeks, 12 weeks
The proportion or participants achieving IIEF-EF domain score ≥ 26 after 6, 12 weeks
Measured: 6 weeks, 12 weeks
The proportion (%) of participants who responded "Yes" to Sexual Encounter Profile (SEP) Questions 1, 2, 3, 4, and 5 at Weeks 6 and 12 compared with baseline
Measured: baseline, 6 weeks, 12 weeks
The proportion of participants who responded "Yes" to Global Assessment Question (GAQ) at Week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899073
- Sponsor's protocol ID
- HM-TAMI-301
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
- ClinicalTrials.gov ID
- NCT07899073
- Acronym / sponsor ID
- HM-TAMI-301
- Conditions
- Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 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.
A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIP2602 + HPP2602-2 | Experimental | Drug: HIP2602 + HPP2602-2Daily administration, oral |
| HPP2602-1 + HPP2602-2 | Placebo comparator | Drug: HPP2602-1 + HPP2602-2Daily administration, oral |
| HGP1201 + HPP2602-1 | Other | Drug: HGP1201 + HPP2602-1Daily administration, oral |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Visit 1 (screening)
- Male subjects aged 19 to 75 years, inclusive.
- Subjects with a history of erectile dysfunction for at least 3 months prior to Visit 1.
- Subjects who are expected to have sexual intercourse with the same adult female partner throughout the study period.
- Subjects who agree to attempt sexual intercourse at least 4 times on 4 separate days during the run-in period.
Key exclusion criteria (12 listed)
- Erectile dysfunction associated with premature ejaculation or endocrine disorders (e.g., hypogonadism, hyperprolactinemia, thyroid disorders)
- Uncontrolled diabetes mellitus (HbA1c > 10% at Visit 1)
- History of radical prostatectomy or other pelvic surgery
- Presence of anatomical penile deformity (e.g., Peyronie's disease, penile angulation, cavernosal fibrosis)
- History of major cardiovascular or cerebrovascular disease, including unstable angina, recent myocardial infarction, stroke, uncontrolled arrhythmia, or heart failure
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 |
|---|---|---|
| HIP2602 + HPP2602-2Test drug | Drug | HIP2602 + HPP2602-2 |
| HPP2602-1 + HPP2602-2Control drug | Drug | HPP2602-1 + HPP2602-2 |
| HGP1201 + HPP2602-1Active Comparator | Drug | HGP1201 + HPP2602-1 |
Primary outcome
Change of IIEF-EF domain score from baseline after 12 weeks
Time frame: baseline, 12 weeks
10 secondary outcomes
Change of IIEF-EF domain score from baseline after 6 weeks
Time frame: baseline, 6 weeks
Change of IIEF-OF domain score from baseline after 6, 12 weeks
Time frame: baseline, 6 weeks, 12 weeks
Change of IIEF-SD domain score from baseline after 6, 12 weeks
Time frame: baseline, 6 weeks, 12 weeks
Change of IIEF-IS domain score from baseline after 6, 12 weeks
Time frame: baseline, 6 weeks, 12 weeks
Change of IIEF-OS domain score from baseline after 6, 12 weeks
Time frame: baseline, 6 weeks, 12 weeks
Change of IIEF Question 3 score from baseline after 6, 12 weeks
Time frame: baseline, 6 weeks, 12 weeks
Change of IIEF Question 4 score from baseline after 6, 12 weeks
Time frame: baseline, 6 weeks, 12 weeks
The proportion or participants achieving IIEF-EF domain score ≥ 26 after 6, 12 weeks
Time frame: 6 weeks, 12 weeks
The proportion (%) of participants who responded "Yes" to Sexual Encounter Profile (SEP) Questions 1, 2, 3, 4, and 5 at Weeks 6 and 12 compared with baseline
Time frame: baseline, 6 weeks, 12 weeks
The proportion of participants who responded "Yes" to Global Assessment Question (GAQ) at Week 12
Time frame: 12 weeks
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 27 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.
Hyun Jun Park contact
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 HIP2602 + HPP2602-2, HPP2602-1 + HPP2602-2 and HGP1201 + HPP2602-1 in people with Erectile Dysfunction, run by Hanmi Pharmaceutical Company Limited 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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 27 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?
Contact Jee Won Shon (82-2-410-9037, jeewon.shon@hanmi.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of IIEF-EF domain score from baseline after 12 weeks (time frame: baseline, 12 weeks). 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 27 Oct 2026.