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NCT00547417 Clinical Trial

To Determine Effect and Safety of Tadalafil Taken by Men of Different Races and With Different Diseases When Needed for Erections

Impotence Clinical Trial

Official title:
An Open-Label Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Men of Various Populations With Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00547417
Other study ID # 7006
Secondary ID H6D-MC-LVFN
Status Completed
Phase Phase 3
First received October 18, 2007
Last updated October 18, 2007
Start date July 2003
Est. completion date March 2004

Study information
Verified date October 2007
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To compare men of different races and those with diabetes or depression to white men that do not have diabetes or depression but also suffer from the inability to get or keep an erection.

Recruitment information / eligibility
Status Completed
Enrollment 1933
Est. completion date March 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- At least 3 months history of erectile dysfunction (ED)

- Anticipate a monogamous relationship with a female sexual partner

- Be able to make minimum required sexual intercourse attempts

- Abstain from using any other ED treatment

Exclusion Criteria:

- Other primary sexual disorders

- History of penile implant or clinically significant penile deformity

- History or current nitrate use

- History of certain heart problems

- History of certain kidney problems

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tadalafil
20 mg tadalafil tablet taken by mouth, as needed, no more than once a day, for 12 weeks.

Locations
Country Name City State
United States 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. Dallas Texas

Sponsors (2)
Lead Sponsor Collaborator
Eli Lilly and Company ICOS Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in the scores of the IIEF scale's Erectile Function domain, questions 1-5 and 15 12 weeks
Secondary Percentage of Yes answers to questions 2 and 3 of the Sexual Encounter Profile 12 weeks
Secondary Evaluation of score changes for selected GAQ, PAIRS, and IIEF questions. 12 weeks
See also
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Completed NCT00654082 - A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction Phase 4
Completed NCT00882934 - The Management of Erectile Dysfunction With Placebo Only N/A
Withdrawn NCT00382161 - Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors Phase 3
Recruiting NCT00297544 - Effect of Sildenafil on Endothelial Function N/A
Completed NCT00249730 - Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function. Phase 4
Completed NCT00245596 - Evaluation of the Index of Sexual Life Questionnaire Phase 4
Completed NCT00547183 - Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection Phase 3
Completed NCT00422578 - Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction Phase 4
Completed NCT00547092 - Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection Phase 4
Completed NCT00547508 - To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking Phase 3
Completed NCT00422734 - Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life Phase 3
Completed NCT00147628 - Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire Phase 4
Completed NCT00301262 - Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied Phase 4
Completed NCT00245258 - Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction Phase 4
Completed NCT00547287 - Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations Phase 3
Completed NCT03830164 - Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer Phase 2
Recruiting NCT00498680 - Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Phase 4
Completed NCT00150358 - To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension . Phase 4
Completed NCT00547495 - Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection Phase 3

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