Effect of Udenafil on Spermatogenesis

Warner Chilcott

Status and phase: Completed; Phase 1

Conditions: Erectile Dysfunction; Spermatogenesis

Treatments: Drug: Placebo; Drug: Udenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01230541

PR-00110

Details and patient eligibility

About

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

Full description

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

Enrollment: 239 patients

Sex: Male

Ages: 25 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

239 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Udenafil

Active Comparator group

Description:

Udenafil daily tablet

Treatment:

Drug: Udenafil