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
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: 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:
Sildenafil
Tadalafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014