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ImpotencePhase 2NCT00174486

Assessment Of Duration Of Action, Safety & Toleration Of UK369,003 and Cialis In Patients With Erectile Dysfunction

A Phase 2 study testing UK0369,003 and Cialis (Tadalafil) in people with Impotence, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Assessment of duration of action, safety \& toleration of different formulations and doses of UK-369,003 and Cialis in patients with male erectile dysfunction. Patients should have previously been on PDE5 inhibitors and have been respondents to the drug. Duration of treatment is 4 weeks. Read more about this study

Who is it for?
Ages 18 to 65 years, men only
Conditions the study is for
Impotence
What is being tested?
UK0369,003 and Cialis (Tadalafil)
How many people
300 participants
Where
No sites listed yet
Study dates
Feb 2005to Jun 2005
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Erectile Dysfunction

Who cannot join

  • Alpha blockers and Nitrates of any preparation

About this study

Official title: A Double Blind, Placebo Controlled, Parallel Group, Multicenter Study To Assess The Duration Of Action, Safety And Toleration Of Differing Doses and Combinations Of Immediate and Modified Release Formulations Of UK-369,003 and Cialis Compared To Placebo In Adult Male Subjects With Erectile Dysfunction

Assessment of duration of action, safety \& toleration of different formulations and doses of UK-369,003 and Cialis in patients with male erectile dysfunction. Patients should have previously been on PDE5 inhibitors and have been respondents to the drug. Duration of treatment is 4 weeks.

Conditions
Impotence
Being tested
UK0369,003, Cialis (Tadalafil)
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UK0369,003Drug

  • Cialis (Tadalafil)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of duration of action, safety & toleration of the investigational drug and Cialis

Secondary outcomes (1)
  1. Assess safety & toleration over 4 week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startFeb 2005
  3. Study completionJun 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00174486
Sponsor's protocol ID
A3711030
Status last verified
Nov 2005
First submitted
12 Sep 2005
Last updated
25 Jul 2006
Results posted
No

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