Viagra vs Hezkue for Erectile Dysfunction

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Aspargo Labs, Inc

Must not be taking: Antihypertensives, PDE5 inhibitors

Disqualifiers: Renal, Hepatic, Cardiovascular, Psychiatric, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two treatments for erectile dysfunction: ASP-001 (an oral liquid) and Viagra (a well-known tablet). Researchers aim to assess how both treatments behave in the body and evaluate their safety and tolerability. Participants will take one treatment, have a short break, and then try the other. Ideal candidates are healthy men who do not smoke and are free of major health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive ASP-001.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications before joining the trial. Specifically, you must not use any prescription or non-prescription drugs, including vitamins and supplements, within seven days before the trial, unless approved by the study team. Additionally, you must avoid antihypertensive medications and PDE5 inhibitors within 14 days of the first dose.

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

A previous study found that ASP-001, an oral spray, was absorbed into the body faster than regular Viagra pills. This faster absorption can be beneficial, but the study also assessed its safety. Some participants reported common side effects such as mouth irritation, dizziness, or headaches. However, the study primarily focused on the spray's effectiveness, not just its safety.

In contrast, Viagra has been used for a long time and is known to be safe for most people. Research has shown that it is generally well-tolerated, even by older men. Many long-term users have reported satisfaction with their treatment and improvements in their sexual activity.

In summary, while ASP-001 is still under study for safety, Viagra has a proven history of safety for most users. Those interested in the trial should consider these findings and discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ASP-001 because it offers a fresh approach to treating erectile dysfunction. Unlike the standard treatments like Viagra, which primarily work by increasing blood flow to the penis, ASP-001 may have a unique mechanism of action or a novel active ingredient that could provide benefits beyond current options. This could mean faster results or effectiveness in patients who don't respond well to existing medications. The combination of ASP-001 with Viagra in different sequences also opens up possibilities for optimizing treatment effects and minimizing side effects.

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

This trial will compare Viagra with ASP-001 for treating erectile dysfunction. Studies have shown that Viagra effectively addresses this condition, with about 82% of men reporting success and achieving successful intercourse 75% of the time. One study found that 92% of men experienced better erections after using Viagra for a year. Research on ASP-001, a new oral spray version of sildenafil, suggests it may act faster than traditional Viagra tablets. ASP-001 absorbs more quickly, potentially leading to faster results for users. Both treatments in this trial are supported by clinical data demonstrating their effectiveness in improving erectile function. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy, fasted male participants who want to help compare the effects of two erectile dysfunction treatments: Viagra and a new drug called Hezkue (ASP-001).

Inclusion Criteria

The 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

I am a healthy man aged between 18 and 55.

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

Exclusion Criteria

I have not used CYP enzyme inducers or St. John's Wort in the last 28 days.

Ingestion of any beverages containing more than 5% fruit juice (fruit drinks, fruit punches, fruit cocktails, fruit-ades, or other products containing 5% or less of fruit juice will be allowed) within 48 hours prior to first dose and for the duration of the study

I received a COVID-19 vaccine within three days before each visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period I

Participants receive either 100 mg of ASP-001 or 100 mg of Viagra

1 day

1 visit (in-person)

Washout

A washout period between treatment periods

6 days

Treatment Period II

Participants receive the alternate treatment (100 mg of ASP-001 or 100 mg of Viagra)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ASP-001
• Viagra

Trial Overview The study is testing how the body processes a liquid form of ASP-001 compared to Viagra tablets. It's an open-label, phase 1 trial where each participant will try both treatments at different times.

How Is the Trial Designed?

Group I: Arm 2 - Viagra and ASP-001 Experimental Treatment 2 Interventions

Participants receive 100 mg of Viagra followed by a 6 day washout before receiving 100 mg of ASP-001

Group II: Arm 1 - ASP-001 and Viagra Experimental Treatment 2 Interventions

Participants receive 100 mg of ASP-001 followed by a 6 day washout before receiving 100 mg of Viagra

Who Is Running the Clinical Trial?

Aspargo Labs, Inc

Lead Sponsor

Trials

2

Recruited

70+

Citations

1. aspargolabs.com aspargolabs.com/aspargo-labs-announces-data-on-first-oral-spray-for-erectile-dysfunction-asp-001-showing-two-times-faster-absorption-compared-to-viagra-tablets/

Aspargo Labs Announces Data on First Oral Spray ... Our research has demonstrated that ASP-001 exhibits rapid absorption, surpassing the absorption rate of Viagra® tablets in the initial minutes ...

2. theeducatedpatient.com theeducatedpatient.com/view/steven-kaplan-md-highlights-faster-acting-sildenafil-oral-spray-for-erectile-dysfunction

Steven Kaplan, MD, Highlights Faster-Acting Sildenafil Oral ... A new sildenafil oral spray, ASP-001, currently under investigation, shows promise in treating erectile dysfunction.

3. urologytimes.com urologytimes.com/view/steven-a-kaplan-md-shares-initial-data-on-sildenafil-oral-spray-vs-tablets

Steven A. Kaplan, MD, shares initial data on sildenafil oral ... Steven A. Kaplan, MD, shares findings from a phase 1 study of ASP-001, an investigational oral formulation of sildenafil for patients with erectile dysfunction.

4. synapse.patsnap.com synapse.patsnap.com/article/aspargo-labs-unveils-data-asp-001-oral-spray-absorbs-twice-as-fast-as-viagraC2AE

Aspargo Labs Unveils Data: ASP-001 Oral Spray Absorbs ... Our research shows that ASP-001 is absorbed more rapidly than Viagra® tablets in the initial minutes after use. We are eager to collaborate with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06782659

Study to Compare the Effects of Viagra® Vs Hezkue® in ... Sequence 2: Viagra in Period I, ASP-001 in Period II. There is a washout period of 6 days between treatment periods. Enrollment may be increased at any point in ...

6. urologytimes.com urologytimes.com/view/sildenafil-oral-spray-achieves-faster-absorption-vs-sildenafil-tablets

Sildenafil oral spray achieves faster absorption vs ... ASP-001, an investigational sildenafil oral spray for patients with erectile dysfunction, achieved therapeutic levels at a significantly faster rate.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07117383

Study Details | NCT07117383 | Hezkue® ... The goal of this clinical trial is to compare how different sildenafil formulations are absorbed and tolerated in healthy adult males under fed conditions.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06782659?term=AREA%5BBasicSearch%5D(PATREX)&rank=3

Study to Compare the Effects of Viagra® Vs Hezkue® in ... Additionally, the study assesses the tolerability of ASP-001, including potential for oral irritation, dizziness, or headache. Participants are randomized to ...