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

NCT ID: NCT00382135

Last Updated: 2007-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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Impotence erectile dysfunction semen sperm Healthy male volunteers men with mild erectile dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

placebo tablet

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo tablet taken by mouth once a day for 40 weeks

2

20 mg tadalafil tablet

Group Type ACTIVE_COMPARATOR

tadalafil

Intervention Type DRUG

20mg tadalafil tablet taken by mouth once a day for 40 weeks

Interventions

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tadalafil

20mg tadalafil tablet taken by mouth once a day for 40 weeks

Intervention Type DRUG

placebo

Placebo tablet taken by mouth once a day for 40 weeks

Intervention Type DRUG

Other Intervention Names

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LY450190 Cialis IC351

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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ICOS Corporation

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

Countries

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United States

Other Identifiers

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H6D-MC-LVFE

Identifier Type: -

Identifier Source: secondary_id

7011

Identifier Type: -

Identifier Source: org_study_id