Determine If the Stress That Comes With Not Developing an Erection Affects Tadalafil Effects

Phase 4

Completed

• Conditions: Impotence
• Interventions: Drug: tadalafil

• Registration Number: NCT00547599
• Lead Sponsor: Eli Lilly and Company

Brief Summary

To determine if patients who are distressed over having problems getting or maintaining an erection react differently to the medication than those who are not stressed over the issue.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study Completion: 2004-01
• 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: 659

Inclusion Criteria

• 3 months history of erectile dysfunction (ED)
• Anticipate a monogamous relationship with a female sexual partner
• Be able to make minimum required sexual intercourse attempts
• Abstain from using any other ED treatment

Exclusion Criteria

• Nitrate use
• Participated in previous tadalafil study or have a current tadalafil prescription
• Heart attack within the last 90 days
• Kidney problems
• Certain heart problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	tadalafil	20 mg tadalafil tablet

Primary Outcome Measures

Name	Time	Method
Change In Spontaneity Domain of PAIRS scale scores	8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in the Time Concerns, Sexual Self-Confidence & Sexual Miscommunication, domains of PAIRS scale scores	8 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.; 🇸🇪 Uppsala, Sweden