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
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, see Learn About Clinical Studies.

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 July 20, 2014