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RecruitingNCT07899073Updated Oct 27, 2026

A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients

A Phase 3 interventional study of HIP2602 + HPP2602-2 and HPP2602-1 + HPP2602-2 in Erectile Dysfunction, sponsored by Hanmi Pharmaceutical Company Limited. Recruiting at 1 site in South Korea. Open to male participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 3, Interventional, and Treatment

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
Male
01

Study summary

A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients

02

Conditions studied

  • Erectile Dysfunction

Browse trials for

03

In context

Erectile Dysfunction

701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.

This study's planned enrollment of 225 is above the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 190 studies on the registry; 11 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria:

  • Erectile dysfunction associated with premature ejaculation or endocrine disorders (e.g., hypogonadism, hyperprolactinemia, thyroid disorders)
  • Uncontrolled diabetes mellitus ( > 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
  • 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 to the study drug or its components
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
225 participants (estimated)

Study arms

  • Experimental
    HIP2602 + HPP2602-2

    Daily administration, oral

    Drug: HIP2602 + HPP2602-2

  • Placebo comparator
    HPP2602-1 + HPP2602-2

    Daily administration, oral

    Drug: HPP2602-1 + HPP2602-2

  • Other
    HGP1201 + HPP2602-1

    Daily administration, oral

    Drug: HGP1201 + HPP2602-1

Interventions

  • DrugHIP2602 + HPP2602-2

    Test drug

  • DrugHPP2602-1 + HPP2602-2

    Control drug

  • DrugHGP1201 + HPP2602-1

    Active Comparator

06

What researchers measure

Primary outcomes

  1. Change of IIEF-EF domain score from baseline after 12 weeks

    Time frame: baseline, 12 weeks

Secondary outcomes

  1. Change of IIEF-EF domain score from baseline after 6 weeks

    Time frame: baseline, 6 weeks

  2. Change of IIEF-OF domain score from baseline after 6, 12 weeks

    Time frame: baseline, 6 weeks, 12 weeks

  3. Change of IIEF-SD domain score from baseline after 6, 12 weeks

    Time frame: baseline, 6 weeks, 12 weeks

  4. Change of IIEF-IS domain score from baseline after 6, 12 weeks

    Time frame: baseline, 6 weeks, 12 weeks

  5. Change of IIEF-OS domain score from baseline after 6, 12 weeks

    Time frame: baseline, 6 weeks, 12 weeks

  6. Change of IIEF Question 3 score from baseline after 6, 12 weeks

    Time frame: baseline, 6 weeks, 12 weeks

  7. Change of IIEF Question 4 score from baseline after 6, 12 weeks

    Time frame: baseline, 6 weeks, 12 weeks

  8. The proportion or participants achieving IIEF-EF domain score ≥ 26 after 6, 12 weeks

    Time frame: 6 weeks, 12 weeks

  9. 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

  10. The proportion of participants who responded "Yes" to Global Assessment Question (GAQ) at Week 12

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07899073
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Oct 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Oct 27, 2026

Study contacts

Jee Won Shon
Contact
jeewon.shon@hanmi.co.kr
82-2-410-9037
Hyun Jun Park
Contact
joon501@naver.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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