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Sponsored by: |
SK Chemicals Co.,Ltd. |
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Information provided by: | SK Chemicals Co.,Ltd. |
ClinicalTrials.gov Identifier: | NCT00351065 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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. |
Estimated Enrollment: | 120 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | March 2005 |
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.
Ages Eligible for Study: | 19 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Definition of erectile dysfunction: “the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.”
Exclusion Criteria:
Hyperprolactinemia: blood prolactin level ≥ 3 X upper limit of normal Low testosterone: blood total testosterone level < lower limit of normal
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
Study ID Numbers: | SK3530_II_2004 |
Study First Received: | July 11, 2006 |
Last Updated: | July 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00351065 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
erectile dysfunction, PDE-5 inhibitor |
Sexual Dysfunctions, Psychological Signs and Symptoms Sexual Dysfunction, Physiological |
Mental Disorders Genital Diseases, Male Erectile Dysfunction |
Sexual and Gender Disorders |