Parkinson's DiseasePhase 4NCT02225548
Sagene 2014 - Parkinson's Disease and Erectile Dysfunction
A Phase 4 study testing Selegiline and Tadalafil in people with Parkinson's Disease and Erectile Dysfunction, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 64 years, men only
- Conditions the study is for
- Parkinson's Disease, Erectile Dysfunction
- What is being tested?
- Selegiline and Tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33612
Tracy Jones, ARNP, 813-974-5909
Theresa Zesiewicz, MD, FAAN
About this study
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.
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
- Being tested
- Selegiline, Tadalafil
- Medical subject headings
- Parkinson Disease, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelegilineDrug
Also called Eldepryl, Zelapar
TadalafilDrug
Also called Cialis, Adcirca
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Selegiline; Drug: Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The IIEF-5 will be administered at Weeks 4, 8, 12 and 16 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theresa Zesiewicz, MD, FAAN, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225548
- Sponsor's protocol ID
- Sagene 2014
- Status last verified
- Dec 2017
- First submitted
- 22 Aug 2014
- Last updated
- 20 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02225548
- Acronym / sponsor ID
- Sagene 2014
- Conditions
- Parkinson's Disease, Erectile Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selegiline and Tadalafil | Experimental | Drug: Selegiline, Drug: TadalafilTadalafil 2.5mg for 4 weeks then oral selegiline 5mg daily for 2 weeks then increased to 5mg twice daily for 2 more weeks |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelegilineAlso: Eldepryl, Zelapar | Drug | Selegiline and Tadalafil |
| TadalafilAlso: Cialis, Adcirca | Drug | Selegiline and Tadalafil |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
Related trials for Parkinson's Disease
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
RecruitingPhase 2/3
A Study of Buntanetap in Participants With PD
Parkinson's Disease (PD), Deep Brain Stimulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Zesiewicz, MD, FAAN principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selegiline and Tadalafil in people with Parkinson's Disease and Erectile Dysfunction, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Shaw, MPH (813-974-5909, jshaw@health.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.