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
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 |
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.
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company | ICOS Corporation |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00159848 -
Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra
|
Phase 4 | |
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 |
NCT00422578 -
Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction
|
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 |
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 |
NCT00245258 -
Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction
|
Phase 4 | |
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 |
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 |
NCT00143221 -
Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)
|
Phase 4 |