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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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21 August 2017 |
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Main ID: |
ISRCTN40898239 |
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Date of registration:
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05/12/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Improving symptoms of intermittent claudication in patients with erectile dysfunction and peripheral vascular disease: a pilot study assessing the benefit of daily dosing with Cialis (tadalafil) 10 mg
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Scientific title:
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Improving symptoms of intermittent claudication in patients with erectile dysfunction and peripheral vascular disease: a pilot study assessing the benefit of daily dosing with Cialis (tadalafil) 10 mg |
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Date of first enrolment:
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19/09/2007 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN40898239 |
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Study type:
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Interventional |
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Study design:
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Prospective randomised double-blind placebo-controlled cross-over pilot study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Graham
Jackson |
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Address:
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Cardiothoracic Centre
6th Floor, East Wing
St Thomas' Hospital
SE1 7EH
London
United Kingdom |
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Telephone:
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+44 (0)20 7188 1055 |
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Email:
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jean.stagg@gstt.nhs.uk |
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male aged 40 - 80 years
2. Erectile dysfunction (Sexual Health Inventory for Men [SHIM] score less than 21)
3. Peripheral vascular disease (PVD) (confirmed by previous ultrasound studies)
Exclusion criteria: 1. Contraindication to PDE 5 inhibitor
2. Inability to undertake an exercise tolerance test
Age minimum:
Age maximum:
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Erectile dysfunction, peripheral vascular disease
Circulatory System
Peripheral vascular disease
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Intervention(s)
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Suitably screened and consenting patients will undertake an Exercise Tolerance Test (ETT) (modified Bruce protocol). Once baseline is established (two tests, 2 weeks apart), Tadalafil 10 mg daily or placebo will be prescribed for a 14 day period. ETT will then be repeated. A weeks wash-out will be observed. A repeat ETT will be undertaken and the patient prescribed either placebo or tadalafil for a further 14 day period. ETT will be repeated. A final follow up occurs one week after this, and with a one week run in, this makes the total duration of this study 7 weeks.
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Primary Outcome(s)
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Total number of minutes/seconds on the exercise treadmill. Time to first report of leg pain will be recorded, measured at the end of weeks 3, 4 and 6
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Secondary Outcome(s)
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Change in score on the Walking Impairment Questionnaire and the Peripheral Artery Disease Symptom Scale, measured at the end of weeks 3, 4 and 6
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Secondary ID(s)
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GJ001 PVD
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Source(s) of Monetary Support
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The Friend's of Guy's Hospital (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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