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

ISRCTN	ISRCTN40898239
DOI	https://doi.org/10.1186/ISRCTN40898239
Secondary identifying numbers	GJ001 PVD

Submission date: 18/09/2007
Registration date: 05/12/2007
Last edited: 10/07/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Graham Jackson
Scientific

Cardiothoracic Centre
6th Floor, East Wing
St Thomas' Hospital
London
SE1 7EH
United Kingdom

Phone	+44 (0)20 7188 1055
Email	jean.stagg@gstt.nhs.uk

Study information

Study design	Prospective randomised double-blind placebo-controlled cross-over pilot study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	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
Study objectives	Daily dosing with the Phosphodiesterase type 5 (PDE 5) inhibitor tadalafil (10 mg) (for a 14-day period) may improve symptoms of claudication in patients with erectile dysfunction and peripheral vascular disease.
Ethics approval(s)	St Thomas' Hospital Local Research Ethics Committee, 09/01/2007, ref: 06/Q0702/162
Health condition(s) or problem(s) studied	Erectile dysfunction, peripheral vascular disease
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Tadalafil
Primary outcome measure	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
Secondary outcome measures	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
Overall study start date	19/09/2007
Completion date	01/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	20
Key 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)
Key exclusion criteria	1. Contraindication to PDE 5 inhibitor 2. Inability to undertake an exercise tolerance test
Date of first enrolment	19/09/2007
Date of final enrolment	01/04/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St Thomas' Hospital

London
SE1 7EH
United Kingdom

Sponsor information

Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development Office
Floor 3, Coneybeare House
Guy's Hospital
St Thomas' Street
London
SE1 9RT
England
United Kingdom

Phone	+44 (0)20 7188 5733
Email	kate.blake@gstt.nhs.uk
Website	http://www.guysandstthomas.nhs.uk/
"ROR"	https://ror.org/00j161312

Funders

Funder type

Charity

The Friend's of Guy's Hospital (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

10/07/2017: No publications found, verifying study status with principal investigator.