Phase 2 Efficacy Study of Sildenafil Products in Adult Men With Erectile Dysfunction

NCT07231185 | Not Yet Recruiting Phase 2

• 1 other identifier: ASP-011-SIL
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn how different sildenafil-based erectile dysfunction (ED) treatments affect erectile function in adult men. The main questions it aims to answer are: Does each assigned product improve erectile function over 12 weeks? What safety or tolerability issues occur when these products are used on an on-demand basis? Researchers will compare Hezkue® and Hezkue Turbo® with several commercially available sildenafil or sildenafil-plus-tadalafil products to see whether there are differences in effectiveness, treatment experience, or safety. Participants will:

• Use one assigned ED treatment on demand for 12 weeks
• Complete electronic diaries and questionnaires about sexual-encounter outcomes and treatment satisfaction
• Attend study visits for safety checks, laboratory tests, and assessments of erectile function

Conditions

Erectile Dysfunction

Keywords

erectile dysfunction; Viagra; sildenafil

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in IIEF-EF Domain Score

  Erectile function will be assessed using the International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, which ranges from 1 to 30, with higher scores indicating better erectile function. Change from baseline to Week 12 will be compared across treatment arms.

  Baseline to Week 12

Secondary Outcomes (9)

• SEP-Q2 Penetration Success Rate

  Weeks 0-12

• SEP-Q3 Intercourse Success Rate

  Weeks 0-12

• Erection Hardness Score (EHS)

  Weeks 4, 8, and 12

• Global Assessment Question (GAQ)

  Week 12

• Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Total Score

  Week 12

Study Arms (10)

Hezkue

EXPERIMENTAL

Participants receive Hezkue®, an oral liquid formulation of sildenafil, used on an on-demand basis for 12 weeks.

Drug: Hezkue

Hezkue Turbo

EXPERIMENTAL

Participants receive Hezkue Turbo®, an oral liquid suspension delivering sildenafil via a metered-dose device, used on an on-demand basis for 12 weeks.

Drug: Hezkue Turbo

Galotam

ACTIVE COMPARATOR

Participants receive Galotam®, a commercially available sildenafil product, used on an on-demand basis for 12 weeks.

Drug: Galotam

BlueChew

ACTIVE COMPARATOR

Participants receive BlueChew® sildenafil chewable tablets, used on an on-demand basis for 12 weeks.

Drug: BlueChew

Pfizer Viagra

ACTIVE COMPARATOR

Participants receive Pfizer Viagra®, a standard oral tablet formulation of sildenafil, used on an on-demand basis for 12 weeks.

Drug: Pfizer Viagra

Aristo Sildaristo

ACTIVE COMPARATOR

Participants receive Aristo Sildaristo®, a commercially available sildenafil tablet product, used on an on-demand basis for 12 weeks.

Drug: Aristo Sildaristo

Lemonaid Health Viagra

ACTIVE COMPARATOR

Participants receive Lemonaid Health-branded sildenafil (Viagra), used on an on-demand basis for 12 weeks.

Drug: Lemonaid Health Sildenafil

Ro Sparks

ACTIVE COMPARATOR

Participants receive Ro Sparks®, a combination sildenafil + tadalafil product, used on an on-demand basis for 12 weeks.

Drug: Ro Sparks

Hims Hard Mints

ACTIVE COMPARATOR

Participants receive Hims Hard Mints®, a combination sildenafil + tadalafil formulation, used on an on-demand basis for 12 weeks.

Drug: Hims Hard Mints

Hello Cake ED Cake Meds

ACTIVE COMPARATOR

Participants receive Hello Cake ED Cake Meds®, a combination sildenafil + tadalafil formulation, used on an on-demand basis for 12 weeks.

Drug: Hello Cake ED Cake Meds

Interventions

Hezkue DRUG

Hezkue® is an oral liquid formulation of sildenafil administered on an on-demand basis for the treatment period.

Also known as: Sildenafil oral spray

Hezkue

Hezkue Turbo DRUG

Hezkue Turbo® is an oral liquid suspension of sildenafil delivered via a metered-dose device, used on an on-demand basis.

Also known as: Sildenafil liquid suspension

Hezkue Turbo

Galotam DRUG

Galotam® is a commercially available sildenafil product administered on an on-demand basis.

Also known as: Sildenafil tablet (Galotam)

Galotam

BlueChew DRUG

BlueChew® sildenafil chewable tablets, used on an on-demand basis.

Also known as: Sildenafil chewable tablet

BlueChew

Pfizer Viagra DRUG

Pfizer Viagra® sildenafil tablets, administered on an on-demand basis.

Also known as: Sildenafil citrate

Pfizer Viagra

Aristo Sildaristo DRUG

Aristo Sildaristo® is a commercially available sildenafil tablet product used on an on-demand basis.

Also known as: Sildenafil

Aristo Sildaristo

Lemonaid Health Sildenafil DRUG

Lemonaid Health-branded sildenafil tablets (Viagra equivalent), administered on an on-demand basis.

Also known as: Sildenafil (Lemonaid Health)

Lemonaid Health Viagra

Ro Sparks DRUG

Ro Sparks® is a combination sildenafil + tadalafil product administered on an on-demand basis.

Also known as: Sildenafil + Tadalafil (Ro Sparks)

Ro Sparks

Hims Hard Mints DRUG

Hims Hard Mints® is a combination formulation containing sildenafil + tadalafil, used on an on-demand basis.

Also known as: Sildenafil + Tadalafil (Hims)

Hims Hard Mints

Hello Cake ED Cake Meds DRUG

Hello Cake ED Cake Meds® is a combination sildenafil + tadalafil product administered on an on-demand basis.

Also known as: Sildenafil + Tadalafil (Hello Cake)

Hello Cake ED Cake Meds

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, 18 to 70 years of age.
• Documented diagnosis of erectile dysfunction (ED) for at least 3 months, confirmed by a clinician.
• Baseline International Index of Erectile Function-Erectile Function (IIEF-EF) domain score ≤25.
• Sexually active and attempting sexual intercourse at least 4 times per month during the 3 months prior to screening.
• Willing and able to attempt sexual intercourse at least once per week during the study.
• Judged by the Investigator to be in good general health other than ED.
• Creatinine clearance (CrCl) \>80 mL/min as calculated by Cockcroft-Gault.
• Able and willing to comply with all study procedures, including use of eDiary/ePRO tools and adherence to dosing instructions.

You may not qualify if:

• Use of nitrates or nitric oxide donors in any form.
• Use of prohibited antihypertensive medications as defined in the protocol.
• Use of phosphodiesterase type 5 (PDE5) inhibitors within 5 days prior to baseline.
• Use of CYP450 inhibitors within 14 days prior to first dose.
• Use of CYP450 inducers or St. John's Wort within 28 days prior to first dose.
• Use of any prescription or non-prescription medications, herbal products, or dietary supplements not approved by the Investigator during the required restriction period.
• Known hypersensitivity to sildenafil, tadalafil, vardenafil, peppermint oil, or any component of the investigational product.
• Clinically significant abnormalities in screening laboratory tests, vital signs, or electrocardiograms, as judged by the Investigator.
• Any hepatic impairment or abnormal liver function test results at screening.
• Positive screening test for hepatitis B surface antigen, hepatitis C antibody, or HIV.
• Clinically significant illness within 30 days prior to the first dose.
• Significant cardiovascular disease, including recent myocardial infarction, unstable angina, uncontrolled hypertension, or severe arrhythmias.
• History of stroke or neurological disorder that may affect sexual function.
• Severe psychiatric disorder or substance abuse that may interfere with study participation.
• Anatomical penile deformity (such as Peyronie's disease) that may interfere with erectile function assessments.

Sponsors & Collaborators

• Aspargo Labs, Inc: lead

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate; Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbolines; Pyridines; Indole Alkaloids; Indoles; Heterocyclic Compounds, 3-Ring

Study Officials

• Mario Guralnik, PhD

  Aspargo Labs, Inc

  STUDY DIRECTOR

Central Study Contacts

Mario Guralnik, PhD

CONTACT

17189381157; avi.berg@synergy-cro.com

Avi Berg

CONTACT

avi.berg@synergy-cro.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 17, 2025
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share