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Male Erectile DysfunctionPhase 2NCT00351065

Phase II Trial of SK3530 in Erectile Dysfunction

A Phase 2 study testing SK3530 in people with Male Erectile Dysfunction, run by SK Chemicals Co., Ltd..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 70 years, men only
Conditions the study is for
Male Erectile Dysfunction
What is being tested?
SK3530
How many people
120 participants
Where
No sites listed yet
Study dates
Sep 2004to Mar 2005
Phase
Phase 2
Are there results?
None posted in the registry

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 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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

About this study

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.

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.

Read the 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.

Being tested
SK3530
Keywords
erectile dysfunction, PDE-5 inhibitor
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SK3530Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IIEF Q3 & Q4

Secondary outcomes (5)

  1. ① Other IFF Questions: Assessment by Domain

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

  3. * SEP: Sexual Encounter Profile

  4. ③ GEAQ(Global Efficacy Assessment Question)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2006 (estimated)
  2. Study startSep 2004
  3. Study completionMar 2005

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
120 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00351065
Sponsor's protocol ID
SK3530_II_2004
Status last verified
Jul 2006
First submitted
11 Jul 2006
Last updated
12 Jul 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SK3530 in people with Male Erectile Dysfunction, run by SK Chemicals Co., Ltd..

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 29 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: stopped early, as of the sponsor's last update on 12 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IIEF Q3 & Q4. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00351065.

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 12 Jul 2006.

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