Depression Trial 4 – Erectile Dysfunction TEST

Here at MAC Clinical Research we are currently running a trial to test a new treatment for depression and erectile dysfunction (ED). You must have depression and ED to take part in this study.

Depression is a mood disorder that causes a persistent feeling of sadness and loss of interest, affecting feelings, thoughts and behaviour that can lead to a variety of emotional and physical illnesses (including sexual problems).

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 study drug is a new compound which works by enhancing the effects of substances in the body to help stimulate an erection. The study drug is being developed in the hope that it will treat depression and ED in men for whom current treatments either do not work or are poorly tolerated.

The main aims of this study are:
• To assess the effect of the study drug on the body
• To assess the safety and tolerability of the study drug
• To see how the body absorbs and removes the study drug

If you are eligible following medical screening, you will receive 2 doses of study medication and one dose of placebo. You will be required to attend 6 visits to the MAC Greater Manchester clinic and on 4 occasions 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 whilst watching an “Adult” film in a private room.

A full description of the study will be given before you decide to take part, both over the phone and during an appointment at the MAC clinic. This will include you receiving the full patient information sheet (PIS). Your GP will also be notified of your participation.

Criteria:

Key Inclusion Criteria*

• Males with depression and erectile dysfunction aged 18 – 55
• BMI 18 – 32 min weight 50kg
• Diagnosis of depression by GP

Key Exclusion Criteria*

• Currently taking anti-depressant medication for depression
• Unable to comply with study visit requirements

​

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.