Sagene 2014 - Parkinson's Disease and Erectile Dysfunction

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 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)