DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017