Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection

This study has been completed.
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00547092
First received: October 18, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.


Condition Intervention Phase
Impotence
Drug: tadalafil
Drug: sildenafil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Open-Label Study to Determine Treatment Preference of Tadalafil (IC351, LY450190) or Sildenafil Citrate in the Oral Treatment of Erectile Dysfunction

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Preference Assessment measured by the Treatment Preference Question [ Time Frame: 26 weeks ]

Secondary Outcome Measures:
  • Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary. [ Time Frame: 0, 12, and 26 weeks ]
  • Assess sexual encounters attributes measured by the PAIRS. [ Time Frame: 0, 12, and 26 weeks ]
  • Measure adverse events through the Side Effect Question. [ Time Frame: 12 and 26 weeks ]

Enrollment: 386
Study Start Date: October 2003
Study Completion Date: November 2004
Arms Assigned Interventions
Active Comparator: 1
tadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks.
Drug: tadalafil
10 mg or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)
Other Names:
  • LY450190
  • Cialis
  • IC351
Active Comparator: 2
sildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks.
Drug: sildenafil
25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)

  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
  • Never taken treatments known as PDE5 inhibitors for erection issues
  • Abstain from using any other erection treatments during the study
  • Anticipate a monogamous female sexual relationship
  • Must be able to make required sexual intercourse attempts

Exclusion Criteria:

  • History of other primary sexual disorder
  • Treatment with nitrates
  • Have a penile implant or clinically significant penile deformity
  • History of certain heart problems
  • Do not meet certain lab value reference ranges
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547092

Locations
United Kingdom
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.
Plymouth, United Kingdom
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: NCT00547092     History of Changes
Other Study ID Numbers: 7002, H6D-MC-LVFL
Study First Received: October 18, 2007
Last Updated: October 18, 2007
Health Authority: European Union: European Medicines Agency

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