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Effect of Udenafil on Spermatogenesis

NCT ID: NCT01230541

Last Updated: 2011-11-30

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

PHASE1

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-11-30

Brief Summary

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Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects on semen characteristics.

Detailed Description

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Safety Study in male subjects with no or mild ED (erectile dysfunction)

Conditions

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Spermatogenesis Erectile Dysfunction

Keywords

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Semen characteristics Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Daily, oral tablet

Udenafil

Udenafil daily tablet

Group Type ACTIVE_COMPARATOR

Udenafil

Intervention Type DRUG

Daily tablet

Interventions

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Placebo

Daily, oral tablet

Intervention Type DRUG

Udenafil

Daily tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No or mild ED (erectile dysfunction) willing \& able to provide 2 semen samples without the use of PDE-5 inhibitor or other excluded medication or devices on 2 separate days during screening and at Weeks 12 \& 26
* BMI (body mass index) between 19 and 31 kilogram/meter squared

Exclusion Criteria

* New onset coronary artery disease within last 3 months, history of myocardial infarction or cardiac surgical procedure within last 6 months or sudden cardiac arrest
* Nitrate medications for angina pectoris
* Used of anti-arrhythmic drug treatment or device
* Congestive heart failure
* Uncontrolled diabetes
* Stroke or transient ischemic attack (TIA) within last 6 months
* Bleeding disorder or history of GI bleeding within last 12 months
* Cancer chemotherapy
* History of alcohol or drug abuse
Minimum Eligible Age

25 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herman Ellman, MD

Role: STUDY_DIRECTOR

Warner Chilcott

Locations

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Warner Chilcott Investigational Site

Huntsville, Alabama, United States

Site Status

Warner Chilcott Investigational Site

Anaheim, California, United States

Site Status

Warner Chilcott Investigational Site

San Diego, California, United States

Site Status

Warner Chilcott Investigational Site

San Diego, California, United States

Site Status

Warner Chilcott Investigational Site

Tarzana, California, United States

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Warner Chilcott Investigational Site

Middlebury, Connecticut, United States

Site Status

Warner Chilcott Investigational Site

Aventura, Florida, United States

Site Status

Warner Chilcott Investigational Site

Clearwater, Florida, United States

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Warner Chilcott Investigational Site

Doral, Florida, United States

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Warner Chilcott Investigational Site

Ocala, Florida, United States

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Warner Chilcott Investigational Site

Pinellas Park, Florida, United States

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Warner Chilcott Investigational Site

Atlanta, Georgia, United States

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Warner Chilcott Investigational Site

Shreveport, Louisiana, United States

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Warner Chilcott Investigational Site

Plainsboro, New Jersey, United States

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Warner Chilcott Investigational Site

Garden City, New York, United States

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Warner Chilcott Investigational Site

Great Neck, New York, United States

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Warner Chilcott Investigational Site

Purchase, New York, United States

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Warner Chilcott Investigational Site

Williamsville, New York, United States

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Warner Chilcott Investigational Site

Cincinnati, Ohio, United States

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Warner Chilcott Investigational Site

San Antonio, Texas, United States

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Warner Chilcott Investigational Site

Webster, Texas, United States

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Warner Chilcott Investigational Site

Norfolk, Virginia, United States

Site Status

Warner Chilcott Investigational Site

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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PR-00110

Identifier Type: -

Identifier Source: org_study_id