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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 22, 2007
Last Update Posted: October 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ICOS Corporation
Information provided by:
Eli Lilly and Company
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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Patient choice of drug at visit 5 [ Time Frame: 14-15 weeks ]

Secondary Outcome Measures:
  • PAIRS self-administered scale scores [ Time Frame: 14-15 weeks ]

Enrollment: 160
Study Start Date: June 2004
Study Completion Date: June 2005
Arms Assigned Interventions
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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547352

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
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

Additional Information:
ClinicalTrials.gov Identifier: NCT00547352     History of Changes
Other Study ID Numbers: 9152
First Submitted: October 18, 2007
First Posted: October 22, 2007
Last Update Posted: October 22, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents