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NCT00382135 Clinical Trial

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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00382135
Other study ID # 7011
Secondary ID H6D-MC-LVFE
Status Completed
Phase Phase 4
First received September 26, 2006
Last updated October 23, 2007
Start date November 2003
Est. completion date December 2005

Study information
Verified date October 2007
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 282
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 45 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tadalafil
20mg tadalafil tablet taken by mouth once a day for 40 weeks
• placebo
Placebo tablet taken by mouth once a day for 40 weeks

Locations
Country Name City State
United States 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

Sponsors (2)
Lead Sponsor Collaborator
Eli Lilly and Company ICOS Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in sperm production measured at baseline and after 9 months of treatment. 40 weeks
Secondary Changes in other semen characteristics and reproductive hormones. 40 weeks
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