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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00547352

Collaborator

ICOS Corporation (Industry)

160

Enrollment

Location

Arms

Duration (Months)

13.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Impotence	Drug: tadalafil Drug: sildenafil	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Jun 1, 2004

Actual Study Completion Date :

Jun 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 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.
Active Comparator: 2 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. Other Names: LY450190 Cialis IC351

Arm

Intervention/Treatment

Active Comparator: 1

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.

Active Comparator: 2

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.

Other Names:

LY450190

Cialis

IC351

Outcome Measures

Primary Outcome Measures

Patient choice of drug at visit 5 [14-15 weeks]

Secondary Outcome Measures

PAIRS self-administered scale scores [14-15 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Lilly Clinical Trial Registry

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00547352

Other Study ID Numbers:

9152
H6D-KL-S002

First Posted:

Oct 22, 2007

Last Update Posted:

Oct 22, 2007

Last Verified:

Oct 1, 2007

Additional relevant MeSH terms:

Erectile Dysfunction

Sildenafil Citrate

Tadalafil

Study Results

No Results Posted as of Oct 22, 2007