NCT00547599

Brief Summary

To determine if patients who are distressed over having problems getting or maintaining an erection react differently to the medication than those who are not stressed over the issue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
659

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2003

Shorter than P25 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

April 1, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
3.8 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 Spontaneity Domain of PAIRS scale scores

    8 weeks

Secondary Outcomes (1)

  • Change in the Time Concerns, Sexual Self-Confidence & Sexual Miscommunication, domains of PAIRS scale scores

    8 weeks

Study Arms (1)

1

ACTIVE COMPARATOR

20 mg tadalafil tablet

Drug: tadalafil

Interventions

tadalafilDRUG

20 mg tadalafil tablet by mouth as needed, no more than once a day for 8 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:

  • 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:

  • Nitrate use
  • Participated in previous tadalafil study or have a current tadalafil prescription
  • Heart attack within the last 90 days
  • Kidney problems
  • Certain heart 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.

Uppsala, Sweden

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
NON RANDOMIZED
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

April 1, 2003

Study Completion

January 1, 2004

Last Updated

October 22, 2007

Record last verified: 2007-10

Locations

SE(1)