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

This study has been completed.

Sponsors and Collaborators:	Eli Lilly and Company ICOS Corporation
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00547352

Purpose

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

Condition	Intervention	Phase
Impotence	Drug: tadalafil Drug: sildenafil	Phase IV

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Sildenafil citrate Sildenafil Citric acid Sodium Citrate Tadalafil

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study
Official Title:	Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Assessment of Treatment Preference

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Secondary Outcome Measures:

Arms	Assigned Interventions
1: Active Comparator sildenafil treatment for at least 10 weeks prior to a 1 week wash out	Drug: 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.
2: Active Comparator Tadalafil treatment for 8 weeks following the 1 week washout period.	Drug: tadalafil 20 mg tadalafil tablets taken by mouth, as needed, no more than once a day for 8 weeks.

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547352

Locations

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, Korea, Republic of

Sponsors and Collaborators

Eli Lilly and Company

ICOS Corporation

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	9152, H6D-KL-S002
Study First Received:	October 18, 2007
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00547352
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Citric Acid

Tadalafil
Sildenafil
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Cardiovascular Agents
Sexual and Gender Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009