Trial Information

Summary: An Open-label, Single-center, Sequential Three-arm, Phase 1 Trial Evaluating the Safety and Potential Activity of hMaxi-K Gene Transfer in Males with Moderate Erectile Dysfunction.

This research study is for patients diagnosed with erectile dysfunction that has been attributed to another medical condition. Even though this medical condition is well-controlled, you may still have impotence sometimes. There are several treatments for impotence that you have tried but these did not work or you did not want to continue with them.

The purpose of this study is to see whether it is safe to inject a single dose of the study drug directly into the penis. You and your partner will be asked to come to the study doctor's office for 8 visits over a period of 6 months. During this time, you and your partner will be asked to answer a series of questions regarding your ability to have intercourse.

Patients MUST have:

• Patients must be adult males at least 18 years or older with erectile dysfunction (ED) and whose ED is attributable to an underlying, stable condition.
• Patients must have been unable to have successful sexual intercourse for 6 months prior to study entry without specific ED therapy like Viagra, Muse, or others.
• Be heterosexual and in a stable, monogamous relationship of at least 6 months duration
• Have a normal physical examination of the penis

Patients MUST NOT have:

• Had within 6 months prior to enrollment myocardial infarction, cerebrovascular accident, arrhythmia, congestive heart failure, unstable angina, require treatment with calcium channel, beta-blocker medication, nitrates or anti-epileptic drugs
• A prior penile prosthetic implant
• A current urinary tract infection
• Peyronie's disease
• Abnormal ECG
• Not have poorly controlled diabetes

If you would like to learn more about participating in this study, please send an e-mail message using the form below.