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Therapeutic Areas: Nephrology/Urology
Disease Category: Erectile Dysfunction

Trial Information

A Randomized, Placebo-controlled, Double-Blind, Parallel Design, Phase 3 Study to Assess the Safety and Efficacy of WC3043 Tablets in Male Subjects with Erectile Dysfunction.

This study is for men 19 years old or older with a history of mild to severe erectile dysfunction (ED) for at least 3 months or longer.

Eligible subjects will be randomly assigned into one of the following four treatment groups: Udenafil 50 mg tablets, Udenafil 100 mg tablets, Udenafil 150 mg tablets or Placebo tablets via oral administration approximately one hour prior to an attempt at sexual intercourse.

Subject's female partner must also be willing to come in for appointments to answer questionnaires.

The duration of this trial is approximately 22 weeks with up to 6 office visits. Both the subject and the partner will be reimbursed $50.00 each per completed visit.

Upon completion of this trial, subjects may enter an open-label, 36-week study where they are guaranteed to be on active medication.

Patient Inclusion Criteria:

• At least 19 years old (no upper age limit)
• History of mild to severe erectile dysfunction (3 months or longer)
• Must be in a monogamous, heterosexual relationship for the length of the study
• Should agree to make at least 4 attempts at intercourse during the screening period
• Must agree not to use any other treatments for ED during the study
• Female partner must sign Informed Consent and be willing to come in for appointments with subject and answer questionnaires
• Female partner must not be pregnant or lactating

Patient Exclusion Criteria:

• Taking nitrate medication in any form
• Uncontrolled Diabetes Mellitus (HbA1c of greater than or equal to13%)
• History of Proliferative Diabetic Retinopathy
• History of dose-limiting adverse effects during therapy with a PDE5 inhibitor or history of consistent treatment failure with other PDE5 inhibitor medications
• Any anatomical deformity of the penis or Peyronie’s Disease
• History of Retinitis Pigmentosa
• History a recent history of drug abuse (alcohol, marijuana, cocaine or opiates)
• Any history of Bipolar Disorder or Psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity or antidepressant use that has not been stable for 3months

Cheryl Nickles, Patient Recruitment Coordinator
Chase Medical Research, LLC
500 Chase Parkway, 3rd Floor
Waterbury, CT 06708
Phone: (203) 419-4404
Fax: (203) 465-7924
EMail: cnickles@chasemr.com

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