NCT00734604|CompletedPhase 3Results

A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.

A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction.

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

12313H6D-CR-S024

Study Type

interventional

Target

378

Locations

9 countries

Sites

Timeline

RegisteredAug 2008

StartedAug 2008

CompletionSep 2009

Brief Summary

The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

378

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Aug 2008

Shorter than P25 for phase_3

Geographic Reach

9 countries

37 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

August 1, 2008

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

November 18, 2010

Completed

Last Updated

November 18, 2010

Status Verified

October 1, 2010

Enrollment Period

1.1 years

First QC Date

August 12, 2008

Results QC Date

September 20, 2010

Last Update Submit

October 21, 2010

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
baseline, 8 weeks of each treatment

Secondary Outcomes (14)

Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS
baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS
baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)
baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection
baseline, 8 weeks of each treatment
+9 more secondary outcomes

Study Arms (6)

T(OaD)/S(PRN)/T(PRN)

EXPERIMENTAL

Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks