Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ED1/2004, Version 2: 25 March 2005
Study information
Scientific title
Acronym
Study hypothesis
Sildenafil after anterior resection for rectal cancer is efficacious in the management of erectile dysfunction.
Ethics approval
Not provided at time of registration
Study design
Randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Erectile dysfunction
Intervention
Sildenafil versus placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Sildenafil citrate
Primary outcome measure
Erectile dysfunction domain score (sum of questions 1-5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire
Secondary outcome measures
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)
Overall trial start date
01/10/2005
Overall trial end date
20/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
50 subjects per group (100 in total)
Participant 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
Recruitment start date
01/10/2005
Recruitment end date
20/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital Birmingham NHS Trust
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
University Hospital Birmingham NHS Foundation Trust (UK)
Sponsor details
Harborne
Birmingham
B15 2TH
United Kingdom
+44 (0)121 472 1311
james.neuberger@uhb.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Pfizer Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/17853038
Publication citations
-
Results
El-Bahnasawy MS, Ismail T, Elsobky E, Alzalouey EI, Bazeed MA, Prognostic factors predicting successful response to sildenafil after radical cystoprostatectomy., Scand. J. Urol. Nephrol., 2008, 42, 2, 110-115, doi: 10.1080/00365590701571563.