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 |
| Protocol serial number | GJ001 PVD |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust (UK) |
| Funder | The Friend's of Guy's Hospital (UK) |
- 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
Scientific
Cardiothoracic Centre
6th Floor, East Wing
St Thomas' Hospital
London
SE1 7EH
United Kingdom
| Phone | +44 (0)20 7188 1055 |
|---|---|
| jean.stagg@gstt.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised double-blind placebo-controlled cross-over pilot study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tadalafil |
| Primary outcome measure(s) | 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 |
| Key secondary outcome measure(s) | 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 |
| Completion date | 01/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/07/2017: No publications found, verifying study status with principal investigator.
