Sildenafil for Erectile Dysfunction

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Aspargo Labs, Inc

Must not be taking: CYP450 inhibitors, CYP450 inducers, PDE5 inhibitors, Nitrates

Disqualifiers: Renal, Hepatic, Cardiovascular, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how different formulations of sildenafil, a medication for erectile dysfunction, are absorbed and tolerated when taken with food. Researchers seek to discover if the new liquid versions, Hezkue and Hezkue Turbo, function differently compared to traditional pills and chewables. Healthy men without serious health issues and with normal kidney function may qualify. Participants will help assess the safety of the new formulations and how they compare to existing products. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to early-stage development.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot use CYP450 enzyme inhibitors within 14 days, CYP450 enzyme inducers or St. John's Wort within 28 days, or certain heart and blood pressure medications within 14 days of dosing.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study tested new versions of sildenafil, called Hezkue and Hezkue Turbo, to assess their safety. The study showed that these versions are generally well-tolerated by healthy adult men. The research focused on how the body absorbs these versions and their overall safety.

For existing sildenafil products, long-term studies have shown they are safe and effective for treating erectile dysfunction (ED) in men. These products have been widely used, with well-documented safety for both short- and long-term use.

Regarding the combination of sildenafil with another drug, tadalafil, studies suggest this combination is generally safe. However, this conclusion is based on past research, and individual experiences may vary.

Overall, these treatments are considered safe, but participants should discuss any concerns with their healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for erectile dysfunction because they introduce innovative formulations of sildenafil. Unlike traditional tablets, the Hezkue formulations offer a liquid form of sildenafil citrate, potentially allowing for faster absorption and quicker onset of action. Additionally, the trial explores the combination of sildenafil with tadalafil in chewable form, which could enhance efficacy and provide a more convenient dosing option. These unique delivery methods could offer significant advantages over standard pill formats, making the treatments potentially more effective and user-friendly.

What evidence suggests that this trial's treatments could be effective for erectile dysfunction?

Research shows that sildenafil effectively treats erectile dysfunction (ED). Studies indicate that about 82% of men using sildenafil can successfully have intercourse, with 75% succeeding most of the time. In this trial, one group of participants will receive Hezkue or Hezkue Turbo, new liquid versions of sildenafil that may be absorbed faster than regular tablets. Early research suggests these liquids might work more quickly. Another group will receive commercially available sildenafil products, including tablets or sildenafil + tadalafil combination chewables. Studies suggest that products combining sildenafil and tadalafil can improve erectile function, especially in severe cases. Overall, sildenafil has a strong history of helping men with ED. ^{1 6 7 8 9}

Who Is on the Research Team?

Mario Guralnik, PhD

Principal Investigator

Aspargo Labs, Inc

Are You a Good Fit for This Trial?

This trial is for healthy adult males who can safely take sildenafil, commonly used for erectile dysfunction. Participants should be able to eat before taking the medication as the study examines absorption with food.

Inclusion Criteria

My kidney function, measured by creatinine clearance, is good.

Participant must be informed of the nature of the study and voluntarily agree to participate by signing an informed consent form prior to any study-specific procedures

Participant must be judged by the Investigator or designee to be in good general health, as documented by medical history, physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG). Any deviations from normal ranges must be assessed and deemed not clinically significant by the Investigator or designee

Exclusion Criteria

History of significant food or drug allergies

Regular alcohol consumption exceeding 15 units per week

I haven't taken CYP450 enzyme inhibitors in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of one of the test products after eating a high-fat meal, followed by blood sampling over a 4-hour period

1 day

1 visit (in-person)

Monitoring

Participants are monitored for side effects and overall health for up to 4 days after each dose

4 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 days

What Are the Treatments Tested in This Trial?

Interventions

• Commercial Sildenafil Products
• Sildenafil/Tadalafil Products

Trial Overview The study is testing how well different forms of sildenafil (Hezkue, Hezkue Turbo, and other commercial products) are absorbed when taken with food. It aims to see if there's a difference in how quickly they work and their safety.

How Is the Trial Designed?

Group I: Hezkue Formulations Experimental Treatment 2 Interventions

Participants in this arm receive a single dose of 100mg (miligrams) of either Hezkue® (ASP-001) or Hezkue Turbo® (ASP-001.1), both liquid formulations containing sildenafil citrate.

Group II: Commercially Available Sildenafil Products Experimental Treatment 1 Intervention

Participants in this arm receive a single dose of one of several comparator products, including commercially available sildenafil tablets or sildenafil + tadalafil combination chewables.

Who Is Running the Clinical Trial?

Aspargo Labs, Inc

Lead Sponsor

Trials

2

Recruited

70+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2387281/

Long-term safety and effectiveness of sildenafil citrate in ... The efficacy, safety, and tolerability of sildenafil in the treatment of men with ED have been demonstrated in numerous studies of 1-year duration or less.

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/211714

Sildenafil for Male Erectile Dysfunction: A Systematic ... However, for men in both categories of ED severity, sildenafil treatment produced significantly better results than placebo treatment for all efficacy outcomes.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2699643/

Sildenafil in the treatment of erectile dysfunction: an overview ... Success with sildenafil, defined as 75% successful intercourse, was reported by 82% of patients with 77% being successful at every attempt (Guay et al 2001).

4. nature.com nature.com/articles/ijir201017

Hardness, function, emotional well-being, satisfaction and ... This report assesses erection hardness, erectile function, emotional well-being, satisfaction (disease related and treatment related) and the overall sexual ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0302283804002362

Efficacy of Sildenafil Citrate at 12 Hours after Dosing In these evaluable patients, 97% and 74% of patients achieved erections that resulted in successful intercourse at 1 hour and 12 hours postdose, respectively.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07177326

Combination Therapy of Tadalafil 2.5mg Plus Sildenafil ... While sildenafil is effective in managing erectile dysfunction ... combination therapy versus tadalafil 5 mg monotherapy for Treatment of Erectile Dysfunction.

7. mayoclinic.org mayoclinic.org/drugs-supplements/sildenafil-oral-route/description/drg-20066989

Sildenafil (oral route) - Side effects & dosage Safety and efficacy have not been established. Sildenafil should never be used in children for erectile dysfunction. In general, sildenafil should not be ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2776545

Combination Therapies for Erectile Dysfunction Cui H, Liu B, Song Z, et al. Efficacy and safety of long-term tadalafil 5 mg once daily combined with sildenafil 50 mg as needed at the ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/and.12216

Efficacy and safety of long‐term tadalafil 5 mg once daily ... Our results indicate that long-term and low-dose tadalafil combined with sildenafil 50 mg as needed is safety. A few limitations of this study ...