Phase II Trial of SK3530 in Erectile Dysfunction
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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.|
- 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?
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351065
|Principal Investigator:||Jae-Seung Paick, Doctor||Seoul National Univ. Hospital|