Erectile Dysfunction Clinical Trial
Official title:
A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Phase 2 Dose Ranging Trial To Assess The Safety and Efficacy of DA-8159 Tablets in Male Subjects With Erectile Dysfunction.
The purpose of this study will be to evaluate the clinical efficacy and safety of DA-8159, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of subjects with erectile dysfunction (ED).
This will be a multi-center, randomized, double-blind, placebo-controlled, parallel-group
study in 300 erectile dysfunction patients. Patients will complete a screening visit (V1) to
determine eligibility for the study based on the International Index of Erectile Function
(IIEF) erectile function (EF) domain scores, patient history and safety measures. Patients
that meet the entrance criteria for this study will enter a 4 week, drug-free run-in period
to establish a baseline for the erectile function domain score and to meet the criteria for
participation in the study.
Patients successfully completing screen will be randomly assigned to one of four treatment
groups at Visit 2 (V2): placebo or one of 3 active drug doses of DA-8159 tablets. Patients
will be given medication for at-home use and will also be given diaries for recording
information regarding sexual encounters, quality of erections and adverse events. At 4-week
intervals for 3 months (V3, V4, V5), patients will return to the clinic to review and
collect SEP diaries, safety data, 12-lead ECG and medication reconciliation. In addition, at
each 4-week interval patients will complete an IIEF, and at Visit 5 will have blood drawn
for safety evaluation.
The primary efficacy end points are: a) the change in score (baseline to Visit 5) for the
Erectile Function domain score of the IIEF, b) change in response, relative to baseline, for
sexual encounter profile (SEP) question 2, and c) change in response, relative to baseline,
for SEP question 3. For DA-8159 tablets to be judged efficacious, the DA-8159 tablet groups
must be shown superior to the placebo group on all three measures.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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