Phase II Trial of SK3530 in Erectile Dysfunction

NCT00351065 | Terminated Phase 2

• 1 other identifier: SK3530_II_2004
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was designed to evaluate the efficacy and safety of the SK3530 tablet and to find the optimal dose and dosage schedule after oral administration to patients with erectile dysfunction.

Conditions

Male Erectile Dysfunction

Keywords

erectile dysfunction, PDE-5 inhibitor

Outcome Measures

Primary Outcomes (1)

• IIEF Q3 & Q4

Secondary Outcomes (5)

• ① Other IFF Questions: Assessment by Domain

• ② SEP Q2 & Q3: Based on the patient's diary

• * SEP: Sexual Encounter Profile

• ③ GEAQ(Global Efficacy Assessment Question)

• : Did the last 4-week treatment improve your erectile function?

Interventions

SK3530 DRUG

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, aged 19 to 70, suffering from erectile dysfunction for at least the past six months.
• Definition of erectile dysfunction: "the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance."
• Subjects who had a stable, heterosexual relationship with a single partner.
• In the case of the sex partner being of childbearing potential age, the partner having consented to use a medically reliable contraceptive such as the pill, injection, or intrauterine device throughout the whole study period. Not applicable if the sex partner was surgically sterilized, underwent hysterectomy, or was one of the cases that were assessed as acceptable by an investigator.
• Subjects who are eligible for study subjects in the screening test.
• Subjects who attempted sexual intercourse four times or more but failed at least 50% of the attempts or more during the four-week run-in period
• Subjects who had 5\~22 scores in the IIEF EF domain during the four-week run-in period
• Subjects who voluntarily decided to participate in the study and sign the informed consent form

You may not qualify if:

• Subjects who had spinal injury or radical prostatectomy
• Subjects who has anatomical deformities of penis (e.g. severe penile fibrosis, Peyronie's disease)
• Subjects who are diagnosed as primary hypoactive sexual desire
• Erectile dysfunction due to neurogenic or endocrine disorders such as hyperprolactinemia, low testosterone, etc.
• Hyperprolactinemia: blood prolactin level ≥ 3 X upper limit of normal Low testosterone: blood total testosterone level \< lower limit of normal
• Subjects who has major psychiatric disorder (including major depression or schizophrenia), and significant neurology disorders (such as neurovascular disorder, etc.) that is not well controlled on treatment
• Known history of alcoholism or substance abuse.
• Hepatic and renal disease Hepatic disease: GOT, GPT ≥ 3 X upper limit of normal Renal disease: blood creatinine ≥ 2.5mg/dl
• Currently uncontrolled diabetes mellitus (HbA1C\>12%)
• Untreated proliferative diabetic retinopathy
• History of stroke, transient ischemic attacks, myocardial infarction, unstable angina, life-threatening arrhythmia, or coronary artery bypass graft surgery within the previous six months
• History of Heart failure of NYHA Class III or IV, or NYHA Class II within the previous six months.
• Hypotension (a resting sitting blood pressure \<90/50 mmHg) or uncontrolled malignant hypertension (a resting sitting blood pressure \>170/100mmHg)
• A blood disease that might cause a priapism, such as sickle cell disease, multiple myeloma, or leukemia
• Known history of retinitis pigmentosa

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

2-(5-(4-(2-hydroxyethyl)piperazin-1-ylsulfonyl)-2-n-propoxyphenyl)-5-ethyl-7-n-propyl-3,5-dihydro-4H-pyrrolo(3,2-d)pyrimidin-4-one dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Jae-Seung Paick, Doctor

  Seoul National Univ. Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 11, 2006
• First Posted: July 12, 2006
• Study Start: September 1, 2004
• Study Completion: March 1, 2005
• Last Updated: July 12, 2006

Record last verified: 2006-07