Official Title: “An Evaluation of Semen Characteristics After 40 Weeks Daily Dosing With 20 mg Tadalafil”

This is a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel design study to evaluate effects on semen characteristics after 40 weeks of daily dosing with 20 mg tadalafil.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Intervention(s) in this Clinical Trial

• Drug: tadalafil
  • 20mg tadalafil tablet taken by mouth once a day for 40 weeks
• Drug: placebo
  • Placebo tablet taken by mouth once a day for 40 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • placebo tablet
• Active Comparator: 2
  • 20 mg tadalafil tablet

Primary Measures

• Change in sperm production measured at baseline and after 9 months of treatment.
  • Time Frame: 40 weeks
    

Secondary Measures

• Changes in other semen characteristics and reproductive hormones.
  • Time Frame: 40 weeks
    

Inclusion Criteria:

• Healthy male subjects or men with mild erectile dysfunction
• At least 45 years of age
• With specified semen characteristics.

Exclusion Criteria:

• Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
• A history of certain endocrine or hormonal abnormalities
• A history of significant testicular/genital abnormalities
• Any significant reproductive abnormality identified at the start of the study.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00382135

Study ID Number: 7011

ClinicalTrials.gov Identifier: NCT00382135

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry