Skip to main content
OpenTrials
Completed

NCT Number: NCT00382135

A Study of Semen Characteristics After 9 Months of Daily Tadalafil 20 mg

This is a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel design study to evaluate effects on semen characteristics after 40 weeks of daily dosing with 20 mg tadalafil.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bothell, Washington, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects or men with mild erectile dysfunction
  • At least 45 years of age
  • With specified semen characteristics.

Exclusion criteria

  • Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
  • A history of certain endocrine or hormonal abnormalities
  • A history of significant testicular/genital abnormalities
  • Any significant reproductive abnormality identified at the start of the study.

Treatment and study plan

Tadalafil

Drug

20mg tadalafil tablet taken by mouth once a day for 40 weeks

Other names: LY450190, Cialis, IC351

Placebo

Drug

Placebo tablet taken by mouth once a day for 40 weeks

Primary outcomes

  1. Change in sperm production measured at baseline and after 9 months of treatment.

    Time frame: 40 weeks

Secondary outcomes

  1. Changes in other semen characteristics and reproductive hormones.

    Time frame: 40 weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • ICOS Corporation

Registry information

Official study title

An Evaluation of Semen Characteristics After 40 Weeks Daily Dosing With 20 mg Tadalafil

Important dates

Study start
2003
Study completion
2005
First posted
Sep 28, 2006
Registry last updated
Oct 25, 2007

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.