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Determine If the Stress That Comes With Not Developing an Erection Affects Tadalafil Effects

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.
ClinicalTrials.gov Identifier: NCT00547599
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : October 22, 2007
ICOS Corporation
Information provided by:
Eli Lilly and Company

Brief Summary:
To determine if patients who are distressed over having problems getting or maintaining an erection react differently to the medication than those who are not stressed over the issue.

Condition or disease Intervention/treatment Phase
Impotence Drug: tadalafil Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 659 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Presence of Distress Due to Erectile Dysfunction Affect the Effect of Tadalafil on Sexual Life and Life Satisfaction?
Study Start Date : April 2003
Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
20 mg tadalafil tablet
Drug: tadalafil
20 mg tadalafil tablet by mouth as needed, no more than once a day for 8 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351

Primary Outcome Measures :
  1. Change In Spontaneity Domain of PAIRS scale scores [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change in the Time Concerns, Sexual Self-Confidence & Sexual Miscommunication, domains of PAIRS scale scores [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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:

  • Nitrate use
  • Participated in previous tadalafil study or have a current tadalafil prescription
  • Heart attack within the last 90 days
  • Kidney problems
  • Certain heart problems

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): NCT00547599

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.
Uppsala, Sweden
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

Additional Information:
ClinicalTrials.gov Identifier: NCT00547599     History of Changes
Other Study ID Numbers: 7989
First Posted: October 22, 2007    Key Record Dates
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
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents