Sagene 2014 - Parkinson's Disease and Erectile Dysfunction

NCT02225548 | Unknown Phase 4

• 1 other identifier: Sagene 2014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if selegiline and tadalafil (generic for Cialis®) results in an improvement in Erectile dysfunction (ED) in male patients with Parkinson's disease (PD) and moderate ED. Male PD patients who have an incomplete response to tadalafil alone will be given both medications to see if the addition of selegiline improves ED symptoms more than tadalafil alone. It is common practice for a medical doctor to prescribe these two drugs to a patient like you. However, there have been no studies conducted to examine the effects of these medications when taken together. Selegiline is normally prescribed for PD patients that are taking carbidopa/levodopa who are not receiving complete benefit from carbidopa/levodopa. Tadalafil is normally prescribed to men who have erectile dysfunction and/or benign prostatic hyperplasia (BPH).

Conditions

Parkinson's Disease; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Changes in International Index of Erectile Function-5 (IIEF-5) score between baseline (Week 8) to end-of-study (Week 16).

  The International Index of Erectile Function (IIEF) is a widely used, multi-dimensional self-report instrument for the evaluation of male sexual function.

  The IIEF-5 will be administered at Weeks 4, 8, 12 and 16 of the study.

Study Arms (1)

Selegiline and Tadalafil

EXPERIMENTAL

Tadalafil 2.5mg for 4 weeks then oral selegiline 5mg daily for 2 weeks then increased to 5mg twice daily for 2 more weeks

Drug: Selegiline; Drug: Tadalafil

Interventions

Selegiline DRUG

Also known as: Eldepryl, Zelapar

Selegiline and Tadalafil

Tadalafil DRUG

Also known as: Cialis, Adcirca

Selegiline and Tadalafil

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Erectile Dysfunction

Interventions

Selegiline; Tadalafil

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Theresa Zesiewicz, MD, FAAN

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Shaw, MPH

CONTACT

813-974-5909; jshaw@health.usf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 26, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

US (1)