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OpenTrials
Completed

NCT Number: NCT00547183

Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection

Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining 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 with your personal physician.

Genthin, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History of erectile dysfunction for at least 3 months.
  • Currently have diabetes mellitus of at least 3 months duration.
  • Agree to not use any other ED treatment during the study.
  • Anticipate the same female sexual partner for the study.
  • Must be willing to make the required number of sexual attempts.

Exclusion criteria

  • History of other primary sexual disorder
  • Treatment with nitrates or potent CYP3A4 inhibitors
  • Have a penile implant or clinically significant penile deformity
  • History of certain heart problems
  • Have kidney or liver problems

Treatment and study plan

Tadalafil

Drug

2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks

Other names: LY450190, Cialis, IC351

Placebo

Drug

Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks

Primary outcomes

  1. Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in the SEP diary

    Time frame: 12 weeks

Secondary outcomes

  1. Change in the GAQ, SEP, IIEF, SEAR, and RSE scores.

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • ICOS Corporation

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
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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