Clinical trial NCT01230541: Effect of Udenafil on Spermatogenesis
Official title: Effect of Udenafil on Spermatogenesis: A Double-blind, Randomized, Placebo-controlled, Parallel-group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Spermatogenesis
Erectile Dysfunction
Keywords: Semen characteristics
Erectile Dysfunction
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2010-10-29
Enrollment: 239
Sex: MALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Sperm Concentration Reduction greater than or equal to 50% at Week 26
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Warner Chilcott Investigational Site
state: Alabama
city: Anaheim
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Tarzana
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Middlebury
country: United States
facility: Warner Chilcott Investigational Site
state: Connecticut
city: Aventura
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Doral
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Ocala
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Shreveport
country: United States
facility: Warner Chilcott Investigational Site
state: Louisiana
city: Plainsboro
country: United States
facility: Warner Chilcott Investigational Site
state: New Jersey
city: Garden City
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Great Neck
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Purchase
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Williamsville
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Warner Chilcott Investigational Site
state: Ohio
city: San Antonio
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Webster
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Warner Chilcott Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
Study officials:
affiliation: Warner Chilcott
name: Herman Ellman, MD
role: STUDY_DIRECTOR
References: