Study Name: ERECTILE DYSFUNCTION
Clinics: Manchester Early Phase Unit
Therapy Area: Erectile Dysfunction
Gender and Age: Males aged 18 - 59 with erectile dysfunction
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).
Reimbursement: £730 plus Travel expenses will be reimbursed, or transport can be provided
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
Other eligibility criteria will apply. Please contact MAC for more information.
Any other information
Eligible patients will receive a comprehensive health screen and study participation will be in collaboration with the patient’s treating physician.