Clinical Trials Directory

Trials / Completed

CompletedNCT02798159

Safety and Efficacy of TD0025 (Rocket1h) for Treatment of Erectile Dysfunction

A Randomized, Placebo Control, Double-blinded, Double-dummy, Phase 2/3 Combination Study to Evaluate the Safety and Efficacy of TD0025 (Rocket1h) Compared With Sildenafil Citrate for Treatment of Erectile Dysfunction

Status
Completed
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
168 (actual)
Sponsor
Vietstar Biomedical Research · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to identify the optimal dose(s) of TD0025 for treatment of erectile dysfunction (phase II) and to investigate if treatment of erectile dysfunction with the optimal dose of TD0025 taken as needed over one month is non-inferior than Sildenafil Citrate taken as needed over one month (phase III)

Conditions

Interventions

TypeNameDescription
DRUGTD0025
DRUGSildenafil Citrate 50mg

Timeline

Start date
2016-05-01
Primary completion
2018-03-01
Completion
2018-07-01
First posted
2016-06-14
Last updated
2018-10-11

Locations

1 site across 1 country: Vietnam

Source: ClinicalTrials.gov record NCT02798159. Inclusion in this directory is not an endorsement.