Erectile Dysfunction Clinical Trial
Official title:
An Open-Label Phase I/IIa Study to Assess the Safety and Tolerability Profile of TR399 in Healthy Volunteers and Erectile Dysfunction Patients
The purpose of this phase I/IIa study is to assess the safety and tolerability profile of TR399 in healthy volunteers and erectile dysfunction patients. This study will be conducted via a single-arm and open-label fashion.
Several oral medications containing PDE5 inhibitors, including sildenafil (Viagra®, Pfizer),
vardenafil (Levitra®, Bayer) and tadalafil (Cialis®, Lilly), have been marketed for the
treatment of ED. Many considerations should be taken before patients are prescribed with PDE5
inhibitor medications, which may cause systemic side effects and should not be taken with
nitrates or alpha-blockers.
The active pharmaceutical ingredient (API) of TR399 is 5% Vardenafil HCl·3H2O. Non-clinical
studies have shown that the topical use of TR399 can enhance erection and sexual behavior in
animal models without causing irritancy and phototoxicity.
This study is designed as a single-arm and open-label fashion in order to explore the safety
and PK of TR399 in healthy volunteers, as well as the safety, PK and efficacy of TR399 in
patients with ED.
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