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OpenTrials
Completed

NCT Number: NCT00547287

Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations

Study to determine if men from around the world prefer sildenafil to tadalafil.

Completed

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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 with your personal physician.

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must be of legal age according to your country.
  • Must have had a history of erectile dysfunction for at least 3 months.
  • Must currently and have been using sildenafil for the last six weeks.
  • Agree to not use any other ED treatment during the study.
  • Anticipate the same female sexual partner for the study.

Exclusion criteria

  • History of other primary sexual disorder
  • Treatment with nitrates
  • Have a penile implant or clinically significant penile deformity
  • History of certain heart problems
  • Do not meet certain lab value reference ranges

Treatment and study plan

Tadalafil

Drug

20 mg tadalafil as needed by mouth no more than once a day for a 4 week initiation period and a 4 weeks treatment period.

Other names: LY450190, Cialis, IC351

Sildenafil

Drug

Current dosage of sildenafil is continued for 4 weeks (no more than once a day) of treatment assessment then the wash-out period will begin.

Primary outcomes

  1. Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase

    Time frame: 14 weeks

Secondary outcomes

  1. Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains.

    Time frame: 26 weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • ICOS Corporation

Registry information

Official study title

Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference

Important dates

Study start
2002
Study completion
2004
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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