CClinicalTrials.gg
CompletedNCT00547599Updated Oct 22, 2007

Determine If the Stress That Comes With Not Developing an Erection Affects Tadalafil Effects

A Phase 4 interventional study of tadalafil in Impotence, sponsored by Eli Lilly and Company. Completed at 1 site in Sweden. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-10-22.

Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
659
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Impotence

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03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 659 is above the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
659 participants (actual)

Study arms

  • Active comparator
    1

    20 mg tadalafil tablet

    Drug: tadalafil

Interventions

  • Drugtadalafil

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

    Also known as: LY450190, Cialis, IC351

06

What researchers measure

Primary outcomes

  1. Change In Spontaneity Domain of PAIRS scale scores

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: 8 weeks

07

Study locations

1 site
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00547599
Lead sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation
First posted
Oct 22, 2007
Start date
Apr 2003
Completion
Jan 2004
Last update
Oct 22, 2007

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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