The Bronx, NYNCT04349059Now EnrollingIRB Ready

Erectile Dysfunction Clinical Trial in The Bronx, NY

Access cutting-edge erectile dysfunction treatment through this clinical trial at a research site in The Bronx. Study-provided care at no cost to qualified participants.

Sponsored by Montefiore Medical Center

Quick Self-Assessment

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Preparing your pre-screening questions…

Expert Care in The Bronx

Access erectile dysfunction specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related erectile dysfunction treatment provided free

Apply for This The Bronx Location

Check if you qualify for this erectile dysfunction clinical trial in The Bronx, NY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to The Bronx

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit The Bronx site if eligible
  4. 4Begin participation

About This Erectile Dysfunction Study in The Bronx

The goal of this study is to determine whether erectile function is impacted by dietary patterns in healthy men with normal erectile function.

Sponsor: Montefiore Medical Center

Who Can Participate

Inclusion Criteria

Subject provides written informed consent and HIPAA authorization in English before any study procedures are conducted.
Subject is taking no medical therapy other than: prn MDIs, medication(s) for anxiety, depression, and/or ADHD (these medications include, but are not limited to, SSRIs, SNRIs, Stimulants), no change in supplements if applicable. The anxiety, depression, and/or ADHD will have been controlled (per report of subject) for the last 6 months.
IIEF score greater or equal to 22
Subject will have had penile-sexual intercourse (either vaginal or anal penetration) within 12 weeks of enrollment.
Male aged 18-35 years old
Lives within commuting distance of Montefiore Health System
Subject's significant other (if applicable) agrees to support the subject during the study
Subject agrees to photograph and share all items consumed/drunk during the dietary intervention
Subject agrees to avoid all illicit drugs, NSAIDS, and alcohol for at least two days prior to Rigiscan™ recording and on the days and nights of Rigiscan™ recording
Subject agrees to refrain from sexual activity for at least 24 hours prior to Rigiscan™ placement and to have no sexual activity on the days and nights of Rigiscan™ recording.
Subject agrees to not view, read, or otherwise consume erotic or pornographic material for 24 hours prior to both the days and nights of Rigiscan™ recording and on the days and nights of Rigiscan™ recording.
Subject agrees to not have an orgasm for 24 hours prior to both the days and nights of RigiscanTM recording and on the days and nights of Rigiscan™ recording.
Subject agrees to come to Montefiore to undergo Rigiscan™ training
Subject agrees to only consume/drink permitted food/beverages.
Subject agrees to attend all in person visits at Montefiore, to begin fasting at 11pm the night before each visit, and to undergo all blood draws/salivary/other testing.
Subject agrees to not use mouthwash or mouth rinses or intentionally spit for the entire duration of the study. Subjects will be asked to refrain from using mouthwash for at least 2 days prior to enrollment. Subject agrees to not brush his teeth in the morning of the day of each study visit. Tooth brushing is otherwise permissible.
BMI \<30, BMI \>=18.5, weight \>110 lbs.
Subject agrees to comply with the study procedures and visits.
Subject exercises for at least 15 minutes at least two times per week
If exercise is done, subjects will exercise for the same amount of time and at a similar intensity each day of Rigiscan™ testing. Otherwise, no exercise will be performed on Rigiscan™ days.
If enrolled, subjects agree to not modify their dietary habits throughout the duration of the study other than during the two evenings and two full days when food is provided.

Exclusion Criteria

Relevant dietary allergy
Vegetarian or Vegan dietary pattern
History of an eating disorder and/or food addiction
Hypertension and or history of hypertension with or without medical treatment. Systolic blood pressure \> 150mmHg and/or diastolic blood pressure \>100mmHg on Visit one. Heart rate \>99 on Visit one. Systolic blood pressure \< 85mmHg and/or diastolic blood pressure \< 50mmHg on Visit one. Heart rate \< 35 on Visit one.
BMI \>=30, BMI \<18.5, or weight \<= 110lbs
Known chronic medical disease other than non-inflammatory musculoskeletal disease, asthma, anxiety, depression, and/or ADHD. Subjects who have had changes in the dosage or type of their medication(s) for anxiety, depression, and/or ADHD within 3 months of enrollment. Subjects who have scheduled or planned medication and/or medication dose changes during the study period. These medication changes include the initiation of a new medication, discontinuation of a medication, modification of medication dose, and/or the route of administration of a medication. Subjects who are taking benzodiazepines and/or beta blockers
History of kidney disease or hyperkalemia
Subject has received an investigational drug within 30 days prior to signing consent
Erectile dysfunction
Has any condition (e.g., psychiatric illness) or situation that, in the investigator's opinion, may confound the study results, or may interfere significantly with the patient's ability to adhere with study procedures
Currently undergoing treatment for Peyronie's Disease
Abnormal Testosterone or Thyroid Stimulating Hormone level
Treated hypogonadism or hypothyroidism
Planned travel during the study
The subject is trans-gender
History of substance abuse in the last 12 months
Illicit drug use, smoking, or vaping within 4 weeks
Upper respiratory illness within two weeks on screening
If profession requires being on call, no overnight or on call duties during the study
Subject reports any communicable skin or venereal disease
Subject reports rash or lesion on the penis or surrounding area.
STOP-Bang score \> 2
Having the diagnosis of Restless Leg Syndrome.
Having insomnia as defined by: Subject with insomnia would have difficulty initiating or maintaining sleep (30 minutes or more at sleep initiation or 30 minutes or more to fall back asleep if wakes during the night). The above occurs at least 3 times per week for at least 1 month. Furthermore, there must be adequate opportunity for sleep and there must be associated morbidity (feels tired during the day). Definition based on: The International Classification of Sleep Disorders - Third Edition (ICSD-3), 2014.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in The Bronx?

Yes, this clinical trial (NCT04349059) has an active research site in The Bronx, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Erectile Dysfunction Treatment Options in The Bronx, NY

If you're searching for erectile dysfunction treatment options in The Bronx, NY, this clinical trial (NCT04349059) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our The Bronx research site is actively enrolling participants for this clinical trial. You'll receive care from experienced erectile dysfunction specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all erectile dysfunction clinical trials near you to find additional studies recruiting in your area.

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