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

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
tadalafil
placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Impotence, erectile dysfunction, semen, sperm, Healthy male volunteers, men with mild erectile dysfunction

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

placebo tablet

20 mg tadalafil tablet

Outcomes

Primary Outcome Measures

Change in sperm production measured at baseline and after 9 months of treatment.

Secondary Outcome Measures

Changes in other semen characteristics and reproductive hormones.

Full Information

First Posted
September 26, 2006
Last Updated
October 23, 2007
Sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00382135
Brief Title
A Study of Semen Characteristics After 9 Months of Daily Tadalafil 20 mg
Official Title
An Evaluation of Semen Characteristics After 40 Weeks Daily Dosing With 20 mg Tadalafil
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Impotence, erectile dysfunction, semen, sperm, Healthy male volunteers, men with mild erectile dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo tablet
Arm Title
2
Arm Type
Active Comparator
Arm Description
20 mg tadalafil tablet
Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Intervention Description
20mg tadalafil tablet taken by mouth once a day for 40 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo tablet taken by mouth once a day for 40 weeks
Primary Outcome Measure Information:
Title
Change in sperm production measured at baseline and after 9 months of treatment.
Time Frame
40 weeks
Secondary Outcome Measure Information:
Title
Changes in other semen characteristics and reproductive hormones.
Time Frame
40 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Bothell
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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