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Treatment of Erectile Dysfunction II

W

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

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

Trial contacts and locations

40

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Data sourced from clinicaltrials.gov

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