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

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vietstar Biomedical Research
• Treatments: Citric Acid; Sildenafil Citrate

Criteria

Main Inclusion Criteria:

• History of Erectile Dysfunction (ED) of at least 1 month duration.

• Anticipate having the same adult female sexual partner during the study.

• Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.

• Sign the informed consent form

Main Exclusion Criteria:

• ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity

• ED caused by untreated or inadequately treated endocrine disease

• Current treatment with doxazocin, nitrates, cancer chemotherapy, or anti-androgens

• Severe renal or hepatic impairment, history of malignant hypertension

• Presence or history of specific heart conditions