HIP2602 for Erectile Dysfunction: Testing a new treatment in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, Phase 3 trial evaluating the efficacy and safety of HIP2602 in men with erectile dysfunction. Eligible participants have a history of ED, are aged 19 to 75, and plan to have regular intercourse with the same partner. After a run-in period, eligible men are randomized to receive HIP2602 in combination with other related compounds versus control formulations, with outcomes assessed using standardized erectile function metrics. The study aims to determine whether HIP2602-based therapies can improve erectile function while monitoring safety in a diverse patient population. Lead sponsor is Hanmi Pharmaceutical Company Limited, with the study conducted at Pusan National University Hospital in Busan, South Korea.

Why it matters

Who can join: the full rules

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:

* 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
* 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

Where it's running

• Pusan National University Hospital
  Busan, South Korea Recruiting

Study contacts

• Study coordinator: Jee Won Shon
• Email: jeewon.shon@hanmi.co.kr
• Phone: 82-2-410-9037

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.