This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
ICOS Corporation
Information provided by:
Eli Lilly and Company Identifier:
First received: September 26, 2006
Last updated: October 23, 2007
Last verified: October 2007
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.

Condition Intervention Phase
Erectile Dysfunction Drug: tadalafil Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Evaluation of Semen Characteristics After 40 Weeks Daily Dosing With 20 mg Tadalafil

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

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

Secondary Outcome Measures:
  • Changes in other semen characteristics and reproductive hormones. [ Time Frame: 40 weeks ]

Enrollment: 282
Study Start Date: November 2003
Study Completion Date: December 2005
Arms Assigned Interventions
Placebo Comparator: 1
placebo tablet
Drug: placebo
Placebo tablet taken by mouth once a day for 40 weeks
Active Comparator: 2
20 mg tadalafil tablet
Drug: tadalafil
20mg tadalafil tablet taken by mouth once a day for 40 weeks
Other Names:
  • LY450190
  • Cialis
  • IC351


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00382135

United States, Washington
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
Sponsors and Collaborators
Eli Lilly and Company
ICOS Corporation
Study Director: 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) Eli Lilly and Company
  More Information

Additional Information: Identifier: NCT00382135     History of Changes
Other Study ID Numbers: 7011
Study First Received: September 26, 2006
Last Updated: October 23, 2007

Keywords provided by Eli Lilly and Company:
erectile dysfunction
Healthy male volunteers
men with mild erectile dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on July 27, 2017