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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00422578
Other study ID # 9113
Secondary ID H6D-HL-LVGD
Status Completed
Phase Phase 4
First received January 16, 2007
Last updated October 23, 2007
Start date October 2004
Est. completion date September 2005

Study information

Verified date October 2007
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority Finland: Ministry of Social Affairs and Health
Study type Interventional

Clinical Trial Summary

Study is a clinical study assessing the effect of oral tadalafil 10mg or 20 mg on psychosocial aspects and quality of life of erectile dysfunction patients and to compare tadalafil with previous oral erectile dysfunction medication. Study period is 13 weeks. Study patients fill in quality of life questionnaires and treatment satisfaction questionnaires.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- have a history of erectile dysfunction (defined as a consistent change in the quality of erection that adversely affects the patient's satisfaction with sexual intercourse)of at least 3 months duration

- have been using any oral prescription medication,but not tadalafil, for erectile dysfunction for a minimum period of 3 months before visit 1

- have responded to previous erectile dysfunction medication as assessed by the investigator

Exclusion Criteria:

- exhibit evidence of clinically significant hepatobiliary disease (including jaundice) at visit 1

- cardiovascular exclusion criteria: history of chronic stable angina treated with nitrates, recent acute cardiovascular events or procedures (myocardial infarction, coronary interventions, stroke, etc.), history of other serious cardiovascular events (e.g. arrhythmias, sudden cardiac arrest, congestive heart failure, etc.), systolic blood pressure <90mmHg or diastolic blood pressure <50mmHg at screening

- receiving treatment with cancer chemotherapy

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
tadalafil


Locations

Country Name City State
Finland 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. Tampere

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company ICOS Corporation

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary On-demand therapy with tadalafil, as measured by the spontaneity domain of the PAIRS questionnaire increases the possibility to spontaneous sexual activity in ED patients compared with any other previous oral ED treatment.
Secondary Estimate the level of quality of life (15D and LiSat-11)in treated ED patients in order to be able to compare it with existing data of the general population and patients suffering from other diseases and symptoms.
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Completed NCT01037218 - Treatment of Erectile Dysfunction II Phase 3
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Recruiting NCT00313898 - Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males Phase 4
Completed NCT00663728 - Assessment of Duration of Erection With Vardenafil 10 mg Phase 4
Completed NCT00421083 - Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury Phase 3
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