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NOT YET RECRUITING
NCT07231185
PHASE2

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

Sponsor: Aspargo Labs, Inc

View on ClinicalTrials.gov

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

Official title: 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)

Key Details

Gender

MALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-01

Completion Date

2026-03

Last Updated

2025-11-19

Healthy Volunteers

No

Interventions

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.