A Study of Semen Characteristics After 9 Months of Daily Tadalafil 20 mg
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: tadalafil (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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, Affiliation: Eli Lilly and Company
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.
Clinical Details
Official title: An Evaluation of Semen Characteristics After 40 Weeks Daily Dosing With 20 mg Tadalafil
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in sperm production measured at baseline and after 9 months of treatment.
Secondary outcome: Changes in other semen characteristics and reproductive hormones.
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Male.
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.
Locations and Contacts
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, United States
Additional Information
Lilly Clinical Trial Registry
Starting date: November 2003
Last updated: October 23, 2007
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