A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
This clinical trial is designed as a randomized, placebo-controlled, single-blind, parallel
design, multi-center, phase 2 clinical trial to evaluate the efficacy and safety of GV1001 in
patients with benign prostatic hyperplasia. Eligible subjects are randomized into a group out
of the three study groups and a placebo group after four weeks of placebo run-in period.
Placebo run-in period is concurrently proceeded as a wash-out period for previous treatment
of benign prostatic hyperplasia, and a placebo is administered intradermally twice with
two-week interval during this period. After that, the randomized subjects receive a study
drug and a placebo intradermally seven times with two-week interval by visiting at Week 0, 2,
4, 6, 8, 10, and 12. After the treatment period, the subjects additionally visit at Week 13
and 16, and the efficacy is evaluated at Week 4, 8, 12, 13, and 16, and the safety is
evaluated over the 16-week period.