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NCT01230541 Clinical Trial

Effect of Udenafil on Spermatogenesis

Erectile Dysfunction Clinical Trial

Official title:
Effect of Udenafil on Spermatogenesis: A Double-blind, Randomized, Placebo-controlled, Parallel-group Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01230541
Other study ID # PR-00110
Secondary ID
Status Completed
Phase Phase 1
First received October 27, 2010
Last updated November 29, 2011
Start date September 2010
Est. completion date November 2011

Study information
Verified date November 2011
Source Warner Chilcott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 239
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 64 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Daily, oral tablet
• Udenafil
Daily tablet

Locations
Country Name City State
United States Warner Chilcott Investigational Site Anaheim California
United States Warner Chilcott Investigational Site Atlanta Georgia
United States Warner Chilcott Investigational Site Aventura Florida
United States Warner Chilcott Investigational Site Cincinnati Ohio
United States Warner Chilcott Investigational Site Clearwater Florida
United States Warner Chilcott Investigational Site Doral Florida
United States Warner Chilcott Investigational Site Garden City New York
United States Warner Chilcott Investigational Site Great Neck New York
United States Warner Chilcott Investigational Site Huntsville Alabama
United States Warner Chilcott Investigational Site Middlebury Connecticut
United States Warner Chilcott Investigational Site Norfolk Virginia
United States Warner Chilcott Investigational Site Ocala Florida
United States Warner Chilcott Investigational Site Pinellas Park Florida
United States Warner Chilcott Investigational Site Plainsboro New Jersey
United States Warner Chilcott Investigational Site Purchase New York
United States Warner Chilcott Investigational Site San Antonio Texas
United States Warner Chilcott Investigational Site San Diego California
United States Warner Chilcott Investigational Site San Diego California
United States Warner Chilcott Investigational Site Shreveport Louisiana
United States Warner Chilcott Investigational Site Spokane Washington
United States Warner Chilcott Investigational Site Tarzana California
United States Warner Chilcott Investigational Site Webster Texas
United States Warner Chilcott Investigational Site Williamsville New York

Sponsors (1)
Lead Sponsor Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sperm Concentration Reduction greater than or equal to 50% at Week 26 Percentage of Subjects with greater than or equal to 50% decrease from baseline in sperm concentration at 26 weeks 26 weeks No
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Completed NCT00667979 - Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse Phase 4
Completed NCT00663728 - Assessment of Duration of Erection With Vardenafil 10 mg Phase 4
Completed NCT00421083 - Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury Phase 3
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