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
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Hezkue® is an oral liquid formulation of sildenafil administered on an on-demand basis for the treatment period.
Hezkue Turbo® is an oral liquid suspension of sildenafil delivered via a metered-dose device, used on an on-demand basis.
Galotam® is a commercially available sildenafil product administered on an on-demand basis.
BlueChew® sildenafil chewable tablets, used on an on-demand basis.
Pfizer Viagra® sildenafil tablets, administered on an on-demand basis.
Aristo Sildaristo® is a commercially available sildenafil tablet product used on an on-demand basis.
Lemonaid Health-branded sildenafil tablets (Viagra equivalent), administered on an on-demand basis.
Ro Sparks® is a combination sildenafil + tadalafil product administered on an on-demand basis.
Hims Hard Mints® is a combination formulation containing sildenafil + tadalafil, used on an on-demand basis.
Hello Cake ED Cake Meds® is a combination sildenafil + tadalafil product administered on an on-demand basis.
Change From Baseline in IIEF-EF Domain Score
Erectile function will be assessed using the International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, which ranges from 1 to 30, with higher scores indicating better erectile function. Change from baseline to Week 12 will be compared across treatment arms.
Time frame: Baseline to Week 12
SEP-Q2 Penetration Success Rate
Proportion of "Yes" responses to Sexual Encounter Profile Question 2 (SEP-Q2: ability to achieve vaginal penetration) across all sexual attempts.
Time frame: Weeks 0-12
SEP-Q3 Intercourse Success Rate
Proportion of "Yes" responses to Sexual Encounter Profile Question 3 (SEP-Q3: ability to maintain erection through completion of intercourse) across all sexual attempts
Time frame: Weeks 0-12
Erection Hardness Score (EHS)
Proportion of participants achieving an EHS ≥3 and ≥4 at Weeks 4, 8, and 12.
Time frame: Weeks 4, 8, and 12
Global Assessment Question (GAQ)
Proportion of participants responding "Yes" to the GAQ ("Has the treatment improved your erections?").
Time frame: Week 12
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Total Score
Participant-reported satisfaction with erectile dysfunction treatment measured using the EDITS questionnaire.
Time frame: Week 12
TSQM-II Scores (Effectiveness, Side Effects, Convenience, Global Satisfaction)
Treatment satisfaction will be assessed using the Treatment Satisfaction Questionnaire for Medication, Version II (TSQM-II). Each TSQM-II domain (Effectiveness, Side Effects, Convenience, and Global Satisfaction) is scored from 0 to 100, with higher scores indicating greater satisfaction in that domain (and fewer perceived side effects on the Side Effects scale).
Time frame: Week 12
Time-to-Onset of Effect
Participant-reported time (in minutes) to erection sufficient for penetration after dosing, recorded via eDiary for each sexual attempt.
Time frame: Weeks 0-12
Duration of Effect
Participant-reported duration (in hours) of erectile effect after dosing, recorded via eDiary.
Time frame: Weeks 0-12
Incidence of Adverse Events (AEs) and Serious AEs (SAEs)
Frequency and severity of treatment-emergent adverse events, including cardiovascular, ophthalmologic, otologic, and other expected PDE5 inhibitor-related events.
Time frame: Screening through Week 13
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.