NCT00382135

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
282

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
Last Updated

October 25, 2007

Status Verified

October 1, 2007

First QC Date

September 26, 2006

Last Update Submit

October 23, 2007

Conditions

Erectile Dysfunction

Keywords

Impotenceerectile dysfunctionsemenspermHealthy male volunteersmen with mild erectile dysfunction

Outcome Measures

Primary Outcomes (1)

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

    40 weeks

Secondary Outcomes (1)

  • Changes in other semen characteristics and reproductive hormones.

    40 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

placebo tablet

Drug: placebo

2

ACTIVE COMPARATOR

20 mg tadalafil tablet

Drug: tadalafil

Interventions

tadalafilDRUG

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

Also known as: LY450190, Cialis, IC351
2
placeboDRUG

Placebo tablet taken by mouth once a day for 40 weeks

1

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Location

Related Links

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 28, 2006

Study Start

November 1, 2003

Study Completion

December 1, 2005

Last Updated

October 25, 2007

Record last verified: 2007-10

Locations

US(1)