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OpenTrials
Completed

NCT Number: NCT00381732

A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction

This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bothell, Washington, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men with erectile dysfunction
  • At least 18 years of age

Exclusion criteria

  • Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
  • A history of certain impotence disorders
  • History of specified pelvic surgery
  • Any significant genital abnormality identified at the start of the study

Treatment and study plan

Tadalafil

Drug

2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.

Other names: LY450190, Cialis, IC351

Placebo

Drug

Placebo tablet taken by mouth once a day for 24 weeks. Placebo patient will receive 5 mg tadalafil tablet during the open label extension.

Primary outcomes

  1. Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil.

    Time frame: 24-128 weeks

Secondary outcomes

  1. Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharmacokinetics of tadalafil 2.5mg and 5mg.

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • ICOS Corporation

Registry information

Official study title

A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5mg and 5mg) Administered Once Daily to Men With Erectile Dysfunction

Important dates

Study start
2003
Study completion
2006
First posted
Sep 28, 2006
Registry last updated
Nov 7, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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