Male Erectile Dysfunction Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00377793 -
Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II
|
Phase 4 |