Skip to main content
OpenTrials
Completed

NCT Number: NCT01230541

Effect of Udenafil on Spermatogenesis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spermatogenesis Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

25 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Warner Chilcott Investigational Site, Huntsville, Alabama, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Daily, oral tablet

Udenafil

Drug

Daily tablet

Primary outcomes

  1. Sperm Concentration Reduction greater than or equal to 50% at Week 26

    Time frame: 26 weeks

    Percentage of Subjects with greater than or equal to 50% decrease from baseline in sperm concentration at 26 weeks

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 29, 2010
Registry last updated
Nov 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.