A Study of Semen Characteristics After 9 Months of Daily Tadalafil 20 mg

Verified by: Eli Lilly and Company, October 2007
First Received: September 26, 2006 | Last Updated: October 23, 2007 | Phase: Phase 4 | Start Date: November 2003
Overall Status: Completed | Estimated Enrollment: 282
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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...

Brief Summary

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

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Eli Lilly and Company Industry

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  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00382135