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

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

Interventions

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.

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.

Sponsors & Collaborators

• Aspargo Labs, Inc

  lead INDUSTRY

Principal Investigators

• Mario Guralnik, PhD · Aspargo Labs, Inc

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-31

Primary Completion

2026-03-31

Completion

2026-03-31