Sagene 2014 - Parkinson's Disease and Erectile Dysfunction

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02225548
• Date of registration: 22/08/2014
• Prospective Registration: Yes
• Primary sponsor: University of South Florida
• Public title: Sagene 2014 - Parkinson's Disease and Erectile Dysfunction
• Scientific title: An Open-label Trial of Oral Selegiline 5 or 10 mg and Tadalafil 2.5mg Co-administration to Male Patients With Parkinson's Disease and Moderate Erectile Dysfunction.
• Date of first enrolment: September 2014
• Target sample size: 10
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02225548
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Tracy Jones, ARNP

• Name: Jessica Shaw, MPH

• Name: Theresa Zesiewicz, MD, FAAN
• Affiliation: University of South Florida

Key inclusion & exclusion criteria

Inclusion Criteria

- Diagnosis of idiopathic Parkinson's disease that is optimally treated (motor
fluctuations <20% of subject's awake time). Subjects may be on levodopa therapy but
must 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 time
of screening

- Diagnosis of moderate erectile dysfunction (defined according to the NIH Consensus
Development Panel on Impotence) for more than 6 months and demonstrating and
incomplete response to tadalafil alone

- Subject demonstrating an IIEF-5 drug-free baseline score that is = 10 but = 16, and an
IIEF-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 without
supplementation

- 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 the
study, including oral medication, vacuum devices, constrictive devices, injections,
urethral suppositories, gels, any over-the-counter or nonprescription medications, and
products purchased via the internet

- Subject receiving dopamine agonists, nitrates, alpha-receptor blocking agents, or
antihypertensive 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 or
hypertension with a resting systolic blood pressure > 170 mmHG or a resting diastolic
blood pressure > 110 mmHG

- Subject with any underlying cardiovascular condition, including unstable angina
pectoris, which preclude sexual activity

- Subject with a history of myocardial infarction, stroke or life-threatening arrhythmia
within 6 months prior to screening

- Subject with uncontrolled atrial fibrillation/flutter at screening (defined as
ventricular response rate = 100 bpm)

- Subject with a bleeding disorder

- Subject with a history of prostatectomy because of prostate cancer, including nerve
sparing techniques. Subjects with a history of surgical procedures for the treatment
of 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 ischemic
optic neuropathy (NAION), history of temporary or permanent loss of vision, including
unilateral loss of vision

- Subject with a history of congenital QT prolongation

- Subject with a penile anatomical abnormality (e.g., penile fibrosis, fractures, or
Peyronie's disease) which, in the investigator's opinion, could significantly impair
sexual performance. This will be based on subject's reported medical history (penile
exam 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-Pugh
B), or severe (Child-Pugh C) hepatic impairment

- Subject with clinically significant chronic hematological disease which could lead to
priapism 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 or
basal cell skin cancer)

- Subject with a history of a positive test for Hepatitis B surface antigen (HbsAg) or
Hepatitis C

- Subject with a known hypersensitivity to any component of the investigational
medications, monoamine oxidase inhibitors, phosphodiesterase type 5 inhibitors or
phenylethylamines

- 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 visit
schedule or study procedures

- Subject with any unstable medical, psychiatric, or substance abuse disorder that in
the opinion of the investigator is likely to affect the subject's ability to complete
the study or preclude the subject's participation in the study

- Diagnosis of any other neurologic disease

- Uncontrolled Diabetes (Hemoglobin A1C > 7.5)



Age minimum: 40 Years
Age maximum: 64 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Erectile Dysfunction

Intervention(s)

Drug: Selegiline

Drug: Tadalafil

Primary Outcome(s)

Changes in International Index of Erectile Function-5 (IIEF-5) score between baseline (Week 8) to end-of-study (Week 16). [Time Frame: The IIEF-5 will be administered at Weeks 4, 8, 12 and 16 of the study.]

Secondary ID(s)

Sagene 2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors