Effect of Udenafil on Spermatogenesis

Phase 1CompletedNCT01230541

Warner Chilcott239 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

239

Conditions

Spermatogenesis Erectile Dysfunction

Interventions

PlaceboDRUG

Daily, oral tablet

UdenafilDRUG

Daily tablet

Eligibility

Sex: MALEMin age: 25 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (23)

Warner Chilcott Investigational Site

Huntsville, Alabama, United States

Outcomes

Primary Outcomes

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

Time frame: 26 weeks

Data from ClinicalTrials.gov

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