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
Timeline
- Start
- 2026-01
- Primary completion
- 2026-03
- Completion
- 2026-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aristo Sildaristo | Unknown | — | Oral |
| Comparator | BlueChew | Unknown | — | Oral |
| Comparator | Galotam | Unknown | — | Oral |
| Subject | Hezkue | Unknown | — | Oral |
| Subject | Hezkue Turbo | Unknown | — | Oral |
| Comparator | Lemonaid Health Sildenafil | Unknown | — | Oral |
| Comparator | Pfizer Viagra | Unknown | — | Oral |
| Comparator | Sildenafil | Unknown | — | Oral |
| Comparator | Tadalafil | Small molecule | — | Oral |