Phase
Condition
Erectile Dysfunction
Dyskinesias
Impotence
Treatment
N/AClinical Study ID
Ages 40-64 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Diagnosis of idiopathic Parkinson's disease that is optimally treated (motorfluctuations <20% of subject's awake time). Subjects may be on levodopa therapy butmust be stable at the time of entry into the study
Sexually active (i.e. ≥1 attempt/week) males, 40 - 64 years of age (inclusive) at timeof screening
Diagnosis of moderate erectile dysfunction (defined according to the NIH ConsensusDevelopment Panel on Impotence) for more than 6 months and demonstrating andincomplete response to tadalafil alone
Subject demonstrating an IIEF-5 drug-free baseline score that is ≥ 10 but ≤ 16, and anIIEF-5 tadalafil-alone baseline score that is ≤ 18
Subject in a stable heterosexual relationship for at least 6 months. (2)
Subject motivated to seek treatment for erectile dysfunction.
Subject with a total serum testosterone level ≥ 300 ng/dL, with or withoutsupplementation
Hoehn and Yahr Scale score of 1 - 3
Patient able to consent and comply with protocol requirements
Exclusion
Exclusion Criteria:
Subject unwilling to cease use of any treatment for erectile dysfunction during thestudy, including oral medication, vacuum devices, constrictive devices, injections,urethral suppositories, gels, any over-the-counter or nonprescription medications, andproducts purchased via the internet
Subject receiving dopamine agonists, nitrates, alpha-receptor blocking agents, orantihypertensive medication (see other exclusionary medications listed below)
Subject with a history of syncope within the last 6 months prior to screening
Subject with symptomatic postural hypotension (severe dizziness or fainting
Subject with hypotension and a resting systolic blood pressure of < 90 mmHG orhypertension with a resting systolic blood pressure > 170 mmHG or a resting diastolicblood pressure > 110 mmHG
Subject with any underlying cardiovascular condition, including unstable anginapectoris, which preclude sexual activity
Subject with a history of myocardial infarction, stroke or life-threatening arrhythmiawithin 6 months prior to screening
Subject with uncontrolled atrial fibrillation/flutter at screening (defined asventricular response rate ≥ 100 bpm)
Subject with a bleeding disorder
Subject with a history of prostatectomy because of prostate cancer, including nervesparing techniques. Subjects with a history of surgical procedures for the treatmentof benign prostate hypertrophy are permitted, with the exception of cryosurgery,cryotherapy or cryoablation
Subject with hereditary degenerative retinal disorders such as retinitis pigmentosa
Subject with a history of loss of vision because of non-arteritic anterior ischemicoptic neuropathy (NAION), history of temporary or permanent loss of vision, includingunilateral loss of vision
Subject with a history of congenital QT prolongation
Subject with a penile anatomical abnormality (e.g., penile fibrosis, fractures, orPeyronie's disease) which, in the investigator's opinion, could significantly impairsexual performance. This will be based on subject's reported medical history (penileexam not required)
Subject with primary hypoactive sexual desire.
Subject with a spinal cord injury
Subject with a severe chronic or acute liver disease, history of moderate (Child-PughB), or severe (Child-Pugh C) hepatic impairment
Subject with clinically significant chronic hematological disease which could lead topriapism such as sickle cell anemia, multiple myeloma, and leukemia
Subject with active peptic ulceration
Subject with a history of malignancy within the past 5 years (other than squamous orbasal cell skin cancer)
Subject with a history of a positive test for Hepatitis B surface antigen (HbsAg) orHepatitis C
Subject with a known hypersensitivity to any component of the investigationalmedications, monoamine oxidase inhibitors, phosphodiesterase type 5 inhibitors orphenylethylamines
Subjects with a history of drug or alcohol abuse within the past 6 months
Subjects currently consuming ≥5 units of alcohol per day
Subject who is illiterate or unable to understand the Informed Consent Form,questionnaires or subject diary
Subject who, in the opinion of the investigator, will be noncompliant with the visitschedule or study procedures
Subject with any unstable medical, psychiatric, or substance abuse disorder that inthe opinion of the investigator is likely to affect the subject's ability to completethe study or preclude the subject's participation in the study
Diagnosis of any other neurologic disease
Uncontrolled Diabetes (Hemoglobin A1C > 7.5)
Study Design
Connect with a study center
University of South Florida
Tampa, Florida 33612
United StatesActive - Recruiting
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