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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00382135
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : October 25, 2007
ICOS Corporation
Information provided by:
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: tadalafil Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Evaluation of Semen Characteristics After 40 Weeks Daily Dosing With 20 mg Tadalafil
Study Start Date : November 2003
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information: Identifier: NCT00382135     History of Changes
Other Study ID Numbers: 7011
First Posted: September 28, 2006    Key Record Dates
Last Update Posted: October 25, 2007
Last Verified: October 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