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Monoamine Oxidase Inhibitor

Selegiline and Tadalafil for Erectile Dysfunction

Phase 4
Waitlist Available
Led By Theresa Zesiewicz, MD, FAAN
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the iief-5 will be administered at weeks 4, 8, 12 and 16 of the study.
Awards & highlights

Study 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).

Eligible Conditions
  • Erectile Dysfunction
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the iief-5 will be administered at weeks 4, 8, 12 and 16 of the study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the iief-5 will be administered at weeks 4, 8, 12 and 16 of the study. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in International Index of Erectile Function-5 (IIEF-5) score between baseline (Week 8) to end-of-study (Week 16).

Trial Design

1Treatment groups
Experimental Treatment
Group I: Selegiline and TadalafilExperimental Treatment2 Interventions
Tadalafil 2.5mg for 4 weeks then oral selegiline 5mg daily for 2 weeks then increased to 5mg twice daily for 2 more weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selegiline
FDA approved
Tadalafil
FDA approved

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor
410 Previous Clinical Trials
186,898 Total Patients Enrolled
Theresa Zesiewicz, MD, FAANPrincipal InvestigatorUniversity of South Florida
1 Previous Clinical Trials
5 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Apr 2025