NCT00547417

Brief Summary

To compare men of different races and those with diabetes or depression to white men that do not have diabetes or depression but also suffer from the inability to get or keep an erection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,933

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_3

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

July 1, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2007

Completed
Last Updated

October 22, 2007

Status Verified

October 1, 2007

First QC Date

October 18, 2007

Last Update Submit

October 18, 2007

Conditions

Impotence

Outcome Measures

Primary Outcomes (1)

  • Change in the scores of the IIEF scale's Erectile Function domain, questions 1-5 and 15

    12 weeks

Secondary Outcomes (2)

  • Percentage of Yes answers to questions 2 and 3 of the Sexual Encounter Profile

    12 weeks

  • Evaluation of score changes for selected GAQ, PAIRS, and IIEF questions.

    12 weeks

Study Arms (1)

1

ACTIVE COMPARATOR

tadalafil

Drug: tadalafil

Interventions

tadalafilDRUG

20 mg tadalafil tablet taken by mouth, as needed, no more than once a day, for 12 weeks.

Also known as: LY450190, Cialis, IC351
1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 3 months history of erectile dysfunction (ED)
  • Anticipate a monogamous relationship with a female sexual partner
  • Be able to make minimum required sexual intercourse attempts
  • Abstain from using any other ED treatment

You may not qualify if:

  • Other primary sexual disorders
  • History of penile implant or clinically significant penile deformity
  • History or current nitrate use
  • History of certain heart problems
  • History of certain kidney problems

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.

Dallas, Texas, 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 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2007

First Posted

October 22, 2007

Study Start

July 1, 2003

Study Completion

March 1, 2004

Last Updated

October 22, 2007

Record last verified: 2007-10

Locations

US(1)