Treatment of Erectile Dysfunction II

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

Treatments: Drug: Placebo; Drug: Udenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01037218

PR-01309

Details and patient eligibility

About

Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).

Full description

Multi-center, randomized, double-blind, placebo-controlled, parallel-group design, Phase 3 pivotal study to investigate the efficacay and safety of 50 mg, 100 mg and 150 mg udenafil tablets compared with placebo in men with ED. This study consisted of a 4-week, treatment free run-in period followed by a treatment period of 12 weeks, with an on-demand dosing regimen.

Enrollment: 601 patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male, at least 19 years of age
• Stable monogamous relationship for at least 6 months with a consenting female partner who is at least 19 years of age, vaginal intercourse is a required study activity
• History of ED (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration
• Partner is not pregnant or lactating

Exclusion criteria

• History of new-onset symptomatic coronary artery disease within the last 3 months or a history of myocardial infarction or cardiac surgical procedure within six months
• Cardiac arrhythmias requiring antiarrhythmic treatment
• Symptomatic congestive heart failure
• Taking nitrate medication in any form
• Uncontrolled diabetes (HbA1c ≥ 13%)
• Hypersensitivity to phosphodiesterase type 5 (PDE-5) inhibitors such as Viagra®, Cialis® or Levitra®
• Previously failed to respond to PDE-5 inhibitors such as Viagra®, Cialis® or Levitra®

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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601 participants in 4 patient groups, including a placebo group

Udenafil 50 mg

Experimental group

Description:

50 mg Udenafil tablet plus 100 \& 150 mg placebo tablets

Treatment:

Drug: Placebo

Drug: Udenafil

Udenafil 100 mg

Experimental group

Description:

100 mg Udenafil tablet plus 50 \& 150 mg placebo tablets

Treatment:

Drug: Placebo

Drug: Udenafil

Udenafil 150mg

Experimental group

Description:

150 mg Udenafil tablet plus 50 \& 100 mg placebo tablets

Treatment:

Drug: Placebo

Drug: Udenafil

Placebo

Placebo Comparator group

Description:

50, 100 \& 150 mg placebo tablets

Treatment:

Drug: Placebo