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NCT00547352 Clinical Trial

Study to Determine a Preference Between Sildenafil or Tadalafil Treatment for Problems Getting an Erection

Impotence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00547352
Other study ID # 9152
Secondary ID H6D-KL-S002
Status Completed
Phase Phase 4
First received October 18, 2007
Last updated October 18, 2007
Start date June 2004
Est. completion date June 2005

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

Clinical Trial Summary

To determine if men with problems getting and keeping an erection prefer treatment with tadalafil or sildenafil.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- History of erection problems

- Anticipate a monogamous female sexual relationship

- Abstain from other erection treatments throughout the study

- Currently use sildenafil

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

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• tadalafil
20 mg tadalafil tablets taken by mouth, as needed, no more than once a day for 8 weeks.
• sildenafil
Current users of sildenafil citrate for a minimum of 6 weeks prior to visit 1 will continue with an individual dosage to be taken no more than once a day for an additional 4 weeks.

Locations
Country Name City State
Korea, Republic of 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. Seoul

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient choice of drug at visit 5 14-15 weeks
Secondary PAIRS self-administered scale scores 14-15 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 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 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 NCT00147628 - Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire 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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