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

This study has been completed.
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00382135
First received: September 26, 2006
Last updated: October 23, 2007
Last verified: October 2007
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Drug Information available for: Tadalafil
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382135

Locations
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
Investigators
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:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00382135     History of Changes
Other Study ID Numbers: 7011, H6D-MC-LVFE
Study First Received: September 26, 2006
Last Updated: October 23, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Tadalafil
Phosphodiesterase 5 Inhibitors
 Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013