Treatment of Erectile Dysfunction I

W

Warner Chilcott

Status and phase

Completed
Phase 3

Conditions

Erectile Dysfunction

Treatments

Drug: Placebo
Drug: Udenafil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01037244
PR-01209

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).

Enrollment

618 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

618 participants in 4 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Udenafil 50 mg
Experimental group
Treatment:
Drug: Udenafil
Udenafil 100 mg
Experimental group
Treatment:
Drug: Udenafil
Udenafil 150 mg
Experimental group
Treatment:
Drug: Udenafil

Trial contacts and locations

36

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Data sourced from clinicaltrials.gov

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