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Home»Parkinson's Disease» Searching for men with Parkinson’s disease and moderate erectile dysfunction to test a drug combination (selegiline and tadalafil)
Clinical Trial
Searching for men with Parkinson’s disease and moderate erectile dysfunction to test a drug combination (selegiline and tadalafil)
This trial is looking at the use of tadalafil (Cialis) and selegiline (Eldepryl) to treat the symptoms of erectile dysfunction (ED) in men with moderate ED and Parkinson's Disease (PD). The main outcome to be measured is the improvement in erectile function. The trial is recruiting in Tampa (Florida), USA.
The details
PD is a progressive disease caused by loss of brain cells that make a substance called dopamine. The loss of these cells can affect functions the nervous system would normally carry out. Sexual function is coordinated by the nervous system. Diseases of the nervous system, such as PD, can, therefore, cause sexual dysfunction such as erectile dysfunction (ED). Tadalafil is a medication commonly prescribed for ED. Selegiline is a medication prescribed for PD. It is important to examine the effects of these medications when taken together.
The main outcome to be measured is a change in erectile function over time.
Who are they looking for?
10 participants are needed for this trial. Participants should be sexually active men with PD who may be treated with levodopa and with moderate ED. Participants should have ED for at least 6 months and in a heterosexual relationship for at least 6 months. Participants should have testosterone levels of 300 nanograms or more (naturally or with supplements).
Participants should not have a history of loss of consciousness, heart attack, stroke or irregular heart rhythm 6 months prior to the study. They also should not have any other cardiovascular (heart and blood vessel) or blood disorders, a history of blindness in one or both eyes, liver diseases, stomach ulcers, any neurological (brain or nervous system) disorders or uncontrolled diabetes. Participants should not have alcoholism or any drug addiction or any cancer diagnosis in the past 5 years. Refusal to stop all other treatments for ED, penis abnormalities such as Peyronie's disease, a spinal cord injury or a low sexual desire will prevent patients from taking part.
How will it work
All participants will receive 2.5mg tadalafil for the first 4 weeks, then 5mg oral selegiline once a day for 2 weeks, which will be increased to 5mg of selegiline twice a day for 2 more weeks. Erectile function changes will be measured through questionnaires at weeks 4, 8, 12 and 16.
