Erectile Dysfunction Clinical Trial
Clinics: Manchester Early Phase Unit
Therapy Area: Erectile Dysfunction
Gender and Age: Males aged 18 – 59 with erectile dysfunction
Reimbursement: £730 plus Travel expenses will be reimbursed, or transport can be provided
About The Research...
MAC Clinical Research is currently running a trial to test a new treatment for Erectile Dysfunction (ED).
The purpose of this study is to test a drug for the potential treatment of erectile dysfunction (ED). Erectile dysfunction is the term used to describe when a man is unable to develop or sustain an erection, which can lead to difficulties in having sexual intercourse. The drugs that are currently available to treat ED work by relaxing the blood vessels in the penis, so more blood can flow through the penis to produce an erection. Although these drugs are effective in treating the condition in some men, approximately 30% to 40% of them do not respond to this treatment.
The study drug is a new compound which works in a different way by enhancing the effects of substances in the body such as dopamine to help stimulate an erection. The study drug is being developed in the hope that it will treat men in whom current treatments for ED do not work.
The main aims of this study are:
- To assess the safety and tolerability of the study drug
- To see how the body absorbs and removes the study drug
- To assess the effect of the study drug on the body
The study will require a Screening visit, 2 x 1-night residential Stays and a Follow up visit.
Whilst at MAC, on the two days you come in, you will be asked to apply a Rigiscan device to your penis. This is a piece of equipment which measures the strength of the erection you get after watching an “Adult” film. This will be done in a private room at various times after you have been dosed with the drug (or placebo).
Eligible patients will receive a comprehensive health screen and study participation will be in collaboration with the patient’s treating physician.
Key Inclusion Criteria
Males with erectile dysfunction aged 18 – 59
BMI 18 – 32
Participant must be heterosexual.
Key Exclusion Criteria
- Concerns about having injections or having blood taken
MAC Clinical Research is currently conducting a research study to test a potential new medical treatment for Erectile Dysfunction.
If you would like more information, please fill in the form below and we will be in touch…
Alternatively, please call our recruitment team on freephone 0800 633 5507.
Data Privacy Statement
The collection and analysis of the most confidential information about people is of fundamental importance for conducting medical research. MAC Research understands that in order for individuals to share their most sensitive information with us, we must have a culture of trust and that we will store data following safe data management practices.
MAC Research Limited (together with its affiliates and subsidiary companies “MAC,” “we,” “us,” and “our”) is committed to ensuring that we handle all individual information in a responsible and careful manner and in accordance with data privacy and confidentiality laws.
Who Are We?
MAC is a leading European clinical research organisation with a network of clinical research centres. MAC provides patient engagement and recruitment services and conducts full scope ethically approved clinical research and medical trials for pharmaceutical companies (“Sponsor”), medical device companies and clinical research organisations. MAC also provides healthcare and consultancy services.
As an employer and clinical research organisation we act as Data Controller over individual personal data and healthcare information. When conducting clinical trials MAC will be regarded as the Data Controller and the Sponsor will be regarded as a Data Processor and participants should consider our respective roles in processing the personal data. For example, with regard to coded clinical trial data provided to Sponsor, MAC is the Data Controller and the Sponsor is a Data Processor of the personal data. Importantly, both act in accordance with the applicable data protection law. Under some particular circumstances, where MAC is involved jointly in determining purpose and/or means of processing data, MAC may be regarded as Joint Controller of Clinical Trials Data.
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Types of Personal Information Managed by MAC Research
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In our capacity as a clinical research organisation providing services for Sponsors, our clinical research sites collect, host and analyse significant quantities of health data and bio-medical samples relating to clinical trial participants. This is because it is necessary to establish the identity of participants accurately and to ensure they are participating in clinical trials that are appropriate for them. MAC is regarded as the Data Controller and the clinical trial Sponsors are considered to be a Data Processor in the terms established by Regulation. However, under some particular circumstances, where MAC is involved jointly in determining purpose and/or means of processing data, MAC may be regarded as Joint Controller of Clinical Trials Data. To adhere to good clinical practice and to ensure the privacy of clinical trial participants is maintained, identification numbers (i.e. not names) are applied to specific clinical trial documentation and any samples taken during the course of clinical trials.
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Data quality and accuracy is essential in clinical trials and MAC understands the vital importance of this. The accuracy of data relating to clinical trial participants is critical for the integrity clinical research, particularly where bio-medical samples are concerned. MAC employs an in-house quality assurance department to ensure that standards are commensurate with all legal requirements. Our privacy notices provide individuals with a straight-forward way of updating and validating information and enabling error corrections. MAC retains personal information for up to 15 years, in accordance with contractual, legal and regulatory requirements. We will retain your information for as long as necessary for the uses set out in this Policy or while there is a legitimate business reason for doing so. If you ask us to delete your information before this time, we may not be able to do so for technical, legal, regulatory or contractual constraints.
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In all other respects, where no overriding interest prevails, MAC will endeavour to allow the following informational rights under this Policy as a matter of good practice:
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Participants enrolled in clinical trials run by MAC’s clients must contact the principal investigator at their MAC research centre, who will be able to identify the participant and progress their request accordingly. The contact details for MAC research centres are available at the following web address: https://researchforyou.co.uk/clinical-trial-centre-locations/
Considerations When Online
Children’s Online Privacy Protection
MAC does not collect information through our websites from individuals who are known to be under the age of 13, and no part of our online presence is directed to anyone less than 13 years.
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Communications, queries, requests to exercise informational rights (e.g., access to data) or complaints can be addressed for the attention of the Data Protection Officer, MAC Research, Kaman Court, 1 Faraday Way, Blackpool, Lancashire, FY2 0JH, United Kingdom.
Within UK individuals have the right in law to complain about how their information is managed to a supervisory authority that is responsible for regulating compliance with the Regulation. The following URL links to the relevant authority https://ico.org.uk/make-a-complaint/your-personal-information-concerns/
Legal Status of Policy and Policy Changes
This Policy is not a contract, and it does not create any legal rights or obligations. MAC reserves the right to modify or amend this Policy and may do so according to new or amended legislation. The updated Policy will be posted on https://www.macplc.com/mac-privacy-policy and https://researchforyou.co.uk/privacy-policy/ (Last Updated: 7 October, 2020).
“I would like to congratulate the amazing team at MAC Clinical Research, based on Faraday Way, Blackpool for all their hard work, dedication and support during my last study. The staff couldn’t have been more courteous, warm and friendly. They all took the time to get to know me as a person as well as a study participant. This resulting in me feeling valued and positive about my future. The Doctor was outstanding and I have so much gratitude and thanks to him for his time and support. I would highly recommend anyone who is considering participating in a study with MAC to take the plunge as the end results can be life changing.”
“Couldn’t have asked for any better support or a better first clinical trial. Really supportive, helped me cope with dark and stressful issues in my life. Hope to come back again in the future. I will miss my visits.”
“Having recently attended MAC for a medical trial, I have to say what a pleasure it was. The trial ran for several weeks and it was like visiting friends on a weekly basis. All the staff from the Receptionist to the Clinicians and the Doctor were really great and most caring. At the same time they were very professional and very thorough, so as to make sure that the trial medication was not affecting my health in any adverse way. I cannot recommend them highly enough.”
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