Phase II Trial of SK3530 in Erectile Dysfunction
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|ClinicalTrials.gov Identifier: NCT00351065|
Recruitment Status : Terminated
First Posted : July 12, 2006
Last Update Posted : July 12, 2006
|Condition or disease||Intervention/treatment||Phase|
|Male Erectile Dysfunction||Drug: SK3530||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||September 2004|
|Study Completion Date :||March 2005|
- IIEF Q3 & Q4
- 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?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351065
|Principal Investigator:||Jae-Seung Paick, Doctor||Seoul National Univ. Hospital|