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| [ ...Back to search results ] | [ Print-friendly version ] |
| A placebo controlled, flexible dose, randomised controlled trial to assess the efficacy of sildenafil citrate in men with erectile dysfunction after anterior resection for rectal carcinoma |
| ISRCTN | ISRCTN86213744 |
| ClinicalTrials.gov identifier | |
| Public title | A placebo controlled, flexible dose, randomised controlled trial to assess the efficacy of sildenafil citrate in men with erectile dysfunction after anterior resection for rectal carcinoma |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | ED1/2004, Version 2: 25 March 2005 |
| Study hypothesis | Sildenafil after anterior resection for rectal cancer is efficacious in the management of erectile dysfunction. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised placebo controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Erectile dysfunction |
| Participants - inclusion criteria |
1. Outpatients aged 18 years or over
2. Resection for tumours of the rectum, and where treatment has been completed 3. Diagnosis of erectile dysfunction (ED) confirmed by a Sexual Health Inventory-Male (SHI-M) score of 21 or less. Erectile dysfunction is defined as 'the inability to achieve and/or maintain an erection of the penis sufficient to permit satisfactory sexual performance' (Impotence National Institutes of Health [NIH] Consensus Conference, JAMA 1993, 270: 83-90). 4. In a stable relationship 5. Written informed consent obtained |
| Participants - exclusion criteria |
1. Unwilling or unable (i.e. not in a sexual relationship) to engage in sexual activity during the 12 week treatment period
2. Current prescription for and/or taking nitrates or nitric oxide donors in any form (oral, sublingual, transdermal, inhaled) on either a regular or intermittent basis 3. Current prescription for nicorandil 4. History of intolerance or hypersensitivity to morphine (or to any other opiates) or to any component of the tablet formulations of sildenafil 5. Previously prescribed pharmacological treatment for ED (any other non-pharmacological treatment (e.g. vacuum devices) for ED must be terminated on or before the screening visit and must not be used at any time during the study) 6. Receipt of a new, or a change to existing, medication known to be causally associated with ED such as but not limited to beta-blockers, thiazide diuretics or antidepressants, within the two weeks prior to screening 7. Concomitant treatment, due to requirement of dosage adjustment, with ritonavir, other protease inhibitors, erythromycin, ketoconazole, cimetidine or other CYP3A4 inhibitors 8. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol 9. Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study 10. Genital anatomical deformities that would significantly impair erections (e.g. severe penile fibrosis) 11. Predisposition to priapism 12. Active peptic ulcer 13. Requirement for a 25 mg starting dose of sildenafil, in the opinion of the investigator 14. Significant cardiovascular disease including cardiac failure, myocardial infarction, unstable angina, stroke, symptomatic or clinically significant cardiac arrhythmias in the last six months, uncontrolled hypertension, hypotension or history of postural hypotension, or judged by the investigator to be cardiovascularly unfit for sexual activity 15. Known history of retinitis pigmentosa 16. Any medical (including known history of major haematological, renal or hepatic abnormalities) or psychological condition or social circumstances that may increase risk to themselves or others by participating or would impair their ability to participate reliably in the study (unwilling or unable to complete Event Log worksheets or questionnaires consistently and accurately) 17. Intention to donate blood or blood products during the period of the study |
| Anticipated start date | 01/10/2005 |
| Anticipated end date | 20/09/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 50 subjects per group (100 in total) |
| Interventions | Sildenafil versus placebo |
| Primary outcome measure(s) | Erectile dysfunction domain score (sum of questions 1-5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire |
| Secondary outcome measure(s) |
1. Responses to the Global Efficacy Assessment Questions (GEAQ)
2. Score of the responses to all the questions of the IIEF Questionnaire 3. Index score of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire 4. Event Log Variables: Percent of Attempts at Intercourse that were successful, Number of Successful Attempts per Week, Number of Attempts per Week 5. Cessation of treatment due to lack of efficacy or intolerable adverse events 6. Quality of life (EORTC QLQ-C30) 7. Responses to the Sexual Health/Quality of Life supplemental questionnaire (SHQL) |
| Sources of funding | Pfizer Ltd (UK) |
| Trial website | |
| Publications | 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/17853038 |
| Contact name | Mr Tariq Ismail |
| Address | University Hospital Birmingham NHS Trust |
| City/town | Birmingham |
| Zip/Postcode | B15 2TH |
| Country | United Kingdom |
| Sponsor | University Hospital Birmingham NHS Foundation Trust (UK) |
| Address | Harborne |
| City/town | Birmingham |
| Zip/Postcode | B15 2TH |
| Country | United Kingdom |
| Tel | +44 (0)121 472 1311 |
| Fax | +44 (0)121 627 283 |
| james.neuberger@uhb.nhs.uk | |
| Sponsor website: | http://www.uhb.nhs.uk |
| Date applied | 15/07/2005 |
| Last edited | 13/10/2009 |
| Date ISRCTN assigned | 10/10/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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