NCT07231185

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

A Phase 2 Open-Label Study to Evaluate the Efficacy, Safety, and Treatment Experience of Hezkue® and Hezkue Turbo® Compared With Select Commercially Available Sildenafil Products in Adult Men With Erectile Dysfunction (ED)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Aspargo Labs, Inc · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

This Phase 2, open-label, parallel-group clinical trial evaluates the real-world use of multiple sildenafil-based erectile dysfunction (ED) treatments, including two oral liquid formulations (Hezkue® and Hezkue Turbo®) and several commercially available tablet, chewable, or combination (sildenafil/tadalafil) products. The study is designed to characterize differences in erectile function outcomes, safety profiles, and patient-reported treatment experiences across these products when used on an on-demand basis. The trial includes a screening period of up to 28 days, followed by 12 weeks of treatment with one assigned product. Participants will use electronic diaries and questionnaires to record sexual-encounter outcomes, timing of effects, treatment satisfaction, and other patient-reported measures. Safety evaluations include adverse event monitoring, vital signs, clinical laboratory assessments, and targeted cardiovascular, ophthalmologic, and otologic examinations. The design reflects typical on-demand PDE5 inhibitor use and enables comparative assessment across distinct formulations and delivery systems (liquid spray, orodispersible/chewable, and standard tablets). Exploratory analyses will examine work productivity, activity impairment, healthcare utilization, and optional partner-reported measures to better understand the broader impact of ED treatment in daily life. This description supplements, but does not repeat, information provided in the Brief Summary, Eligibility, or Outcome Measures sections.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Hezkue	Hezkue® is an oral liquid formulation of sildenafil administered on an on-demand basis for the treatment period.
DRUG	Hezkue Turbo	Hezkue Turbo® is an oral liquid suspension of sildenafil delivered via a metered-dose device, used on an on-demand basis.
DRUG	Galotam	Galotam® is a commercially available sildenafil product administered on an on-demand basis.
DRUG	BlueChew	BlueChew® sildenafil chewable tablets, used on an on-demand basis.
DRUG	Pfizer Viagra	Pfizer Viagra® sildenafil tablets, administered on an on-demand basis.
DRUG	Aristo Sildaristo	Aristo Sildaristo® is a commercially available sildenafil tablet product used on an on-demand basis.
DRUG	Lemonaid Health Sildenafil	Lemonaid Health-branded sildenafil tablets (Viagra equivalent), administered on an on-demand basis.
DRUG	Ro Sparks	Ro Sparks® is a combination sildenafil + tadalafil product administered on an on-demand basis.
DRUG	Hims Hard Mints	Hims Hard Mints® is a combination formulation containing sildenafil + tadalafil, used on an on-demand basis.
DRUG	Hello Cake ED Cake Meds	Hello Cake ED Cake Meds® is a combination sildenafil + tadalafil product administered on an on-demand basis.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-11-17
• Last updated: 2025-11-19