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OpenTrials
Completed

NCT Number: NCT00547573

Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection

Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.

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Key information

Conditions

Impotence 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 to your personal physician.

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History of erection problems
  • Anticipate a monogamous female sexual relationship
  • Abstain from other erection treatments at least 4 weeks before first dose and throughout the study
  • Must be able to make required sexual intercourse attempts

Exclusion criteria

  • Other primary sexual disorders
  • History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
  • History of penile implant or clinically significant penile deformity
  • Nitrate use
  • Certain heart problems

Treatment and study plan

Tadalafil

Drug

10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day

Other names: LY450190, Cialis, IC351

Placebo

Drug

placebo tablet taken by mouth as needed for 12 weeks not more than once a day

Primary outcomes

  1. IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores.

    Time frame: 4, 8, and 12 weeks

Secondary outcomes

  1. IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • ICOS Corporation

Registry information

Official study title

A Multinational, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Asian Men With Erectile Dysfunction

Important dates

Study start
2003
Study completion
2003
First posted
Oct 22, 2007
Registry last updated
Oct 22, 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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