A Study of Semen Characteristics After 9 Months of Daily... | NCT00382135

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

NCT00382135

Sponsor

Eli Lilly and Company

Status

Completed

Last Update Posted

Oct 25, 2007Estimated

Enrollment

282Actual

Phase

Phase 4

Conditions

Erectile Dysfunction

Interventions

tadalafil
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
H6D-MC-LVFE

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Not provided

Completion Date

Dec 2005Actual

First Submitted Date

Sep 26, 2006

First Submission Date that Met QC Criteria

Sep 27, 2006

First Posted Date

Sep 28, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2007

Last Update Posted Date

Oct 25, 2007Estimated

Name	Class
ICOS Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

282Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	placebo tablet	Drug: placebo
2	Active Comparator	20 mg tadalafil tablet	Drug: tadalafil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tadalafil	Drug	20mg tadalafil tablet taken by mouth once a day for 40 weeks	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in sperm production measured at baseline and after 9 months of treatment.		40 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in other semen characteristics and reproductive hormones.		40 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
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

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068581	Tadalafil

Ancestor Terms

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided