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

Impotence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547092
• Other study ID #: 7002
• Secondary ID: H6D-MC-LVFL
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2007
• Last updated: October 18, 2007
• Start date: October 2003
• Est. completion date: November 2004

Study information

• Verified date: October 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impotence

Intervention

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)
• 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)

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	ICOS Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preference Assessment measured by the Treatment Preference Question		26 weeks
Secondary	Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary.		0, 12, and 26 weeks
Secondary	Assess sexual encounters attributes measured by the PAIRS.		0, 12, and 26 weeks
Secondary	Measure adverse events through the Side Effect Question.		12 and 26 weeks

External Links

•   Lilly Clinical Trial Registry