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

Phase 4

Completed

• Conditions: Impotence
• Interventions: Drug: tadalafil; Drug: sildenafil

• Registration Number: NCT00547092
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study Completion: 2004-11
• Status Verified: 2007-10
• Study First Submitted: 2007-10-18
• Study First Submitted QC: 2007-10-18
• Last Update Submitted: 2007-10-18
• Study First Posted: 2007-10-22
• Last Update Posted: 2007-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 386

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	tadalafil	tadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks.
2	sildenafil	sildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Preference Assessment measured by the Treatment Preference Question	26 weeks

Secondary Outcome Measures

Name	Time	Method
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
Assess sexual encounters attributes measured by the PAIRS.	0, 12, and 26 weeks
Measure adverse events through the Side Effect Question.	12 and 26 weeks

Trial Locations

Locations (1)

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