Sagene 2014 - Parkinson's Disease and Erectile Dysfunction
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|ClinicalTrials.gov Identifier: NCT02225548|
Recruitment Status : Recruiting
First Posted : August 26, 2014
Last Update Posted : December 20, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Erectile Dysfunction||Drug: Selegiline Drug: Tadalafil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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.|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: Selegiline and Tadalafil
Tadalafil 2.5mg for 4 weeks then oral selegiline 5mg daily for 2 weeks then increased to 5mg twice daily for 2 more weeks
- 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. ]The International Index of Erectile Function (IIEF) is a widely used, multi-dimensional self-report instrument for the evaluation of male sexual function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02225548
|Contact: Jessica Shaw, MPHfirstname.lastname@example.org|
|United States, Florida|
|University of South Florida||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Tracy Jones, ARNP 813-974-5909|
|Principal Investigator: Theresa Zesiewicz, MD, FAAN|
|Principal Investigator:||Theresa Zesiewicz, MD, FAAN||University of South Florida|