Phase II Trial of SK3530 in Erectile Dysfunction

This study has been terminated.
Sponsor:
Information provided by:
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00351065
First received: July 11, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Male Erectile Dysfunction
Drug: SK3530
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: an 8week, Multi-Center, Randomized, Double Blind, Placebo-Controlled,Parallel Group, Fixed Dose, Dose-Finding Study to Assess the Efficacy and Safety of SK3530 in Patients With Erectile Dysfunction.

Resource links provided by NLM:


Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:
  • IIEF Q3 & Q4

Secondary Outcome Measures:
  • 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?

Estimated Enrollment: 120
Study Start Date: September 2004
Estimated Study Completion Date: March 2005
Detailed Description:

Double-blind, Placebo-controlled, randomized, parallel group, fixed dose, multi-center dose-finding study.

The patients voluntarily signed the informed consent form of the clinical study and underwent a screening. After completing the four-week run-in period, they were randomly assigned to either a placebo group or one of the three SK3530 groups: 50mg, 100mg, and 150mg. The study was conducted in a double-blind manner. A different dose of SK3530 was administered to the subjects depending on the assigned treatment group for 8 weeks. Patient’s visit took place at week 4 and week 8 after randomization and at 6 or 7days after end of study.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • History of serious intestinal bleeding disorder within the past year
  • Subjects who had been prescribed Viagra®, Cialis®, Levitra®, intracavernosal injection or other medication to treat erectile dysfunction within the one week prior to screening.
  • Subjects who are taking one of the following:

    • Nitrates/Nitric oxide (NO) donors (e.g. nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate/nitrite, sodium nitroprusside)

      • Anticoagulant (except for anti-platelet agent)

        • Medicines affecting on CYP3A4 metabolism (e.g. erythromycin, itraconazole, ketoconazole, ritonavir, saquinavir, amprenavir, indinavir, nelfinavir, cimetidine)

          • Androgens (e.g. testosterone) or Anti-androgens

            • Trazodone
  • Known allergic hypersensitivity to other PDE-5 inhibitors such as Viagra®, Cialis®, Levitra®
  • Known no responder to previous treatment with Viagra®, Cialis® or Levitra®
  • Subjects who had taken other clinical trial medicine (including a placebo treatment) within the previous 30 days.
  • Subjects who are unable or unwilling to keep a patient diary
  • Subjects who illiterate or unable to understand questionnaires or a patient diary
  • Subjects who have any other clinical condition, which would interfere with the assessment of study results, in the opinion of the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351065

Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Investigators
Principal Investigator: Jae-Seung Paick, Doctor Seoul National Univ. Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00351065     History of Changes
Other Study ID Numbers: SK3530_II_2004
Study First Received: July 11, 2006
Last Updated: July 11, 2006
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by SK Chemicals Co.,Ltd.:
erectile dysfunction, PDE-5 inhibitor

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014