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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: ICOS Corporation
• Treatments: Tadalafil

Criteria

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.