Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

239

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Sep 2010

Geographic Reach

1 country

23 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

September 1, 2010

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2010

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed

Last Updated

November 30, 2011

Status Verified

November 1, 2011

Enrollment Period

1.2 years

First QC Date

October 27, 2010

Last Update Submit

November 29, 2011

Conditions

Spermatogenesis Erectile Dysfunction

Keywords

Semen characteristicsErectile Dysfunction

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Udenafil

ACTIVE COMPARATOR

Udenafil daily tablet

Drug: Udenafil

Interventions

PlaceboDRUG

Daily, oral tablet

Placebo

UdenafilDRUG

Daily tablet

Udenafil

Eligibility Criteria

Age25 Years - 64 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.