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NCT00381732 Clinical Trial

A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:
A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5mg and 5mg) Administered Once Daily to Men With Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00381732
Other study ID # 7019
Secondary ID H6D-MC-LVFP
Status Completed
Phase Phase 3
First received September 26, 2006
Last updated November 6, 2007
Start date October 2003
Est. completion date June 2006

Study information
Verified date November 2007
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction.

Recruitment information / eligibility
Status Completed
Enrollment 280
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Men with erectile dysfunction

- At least 18 years of age

Exclusion Criteria:

- Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV

- A history of certain impotence disorders

- History of specified pelvic surgery

- Any significant genital abnormality identified at the start of the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tadalafil
2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.
• placebo
Placebo tablet taken by mouth once a day for 24 weeks. Placebo patient will receive 5 mg tadalafil tablet during the open label extension.

Locations
Country Name City State
United States 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. Bothell Washington

Sponsors (2)
Lead Sponsor Collaborator
Eli Lilly and Company ICOS Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil. 24-128 weeks
Secondary Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharmacokinetics of tadalafil 2.5mg and 5mg. 24 weeks
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Completed NCT00667979 - Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse Phase 4
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