Clinical Trial

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

Not Yet Recruiting Phase 2
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Record status
This record was last updated November 19, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-14.
Trial Details
NCT Number NCT07231185
Lead Sponsor Aspargo Labs, Inc
Conditions Erectile Dysfunction
Enrollment 200 participants
Start Date 2026-01
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-11-19