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

This study has been completed.
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00547352
First received: October 18, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Tadalafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014