Phase II Trial of SK3530 in 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.
|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.