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)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Change From Baseline in IIEF-EF Domain Score
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, 18 to 70 years of age.
- •Documented diagnosis of erectile dysfunction (ED) for at least 3 months, confirmed by a clinician.
- •Baseline International Index of Erectile Function-Erectile Function (IIEF-EF) domain score ≤
- •Sexually active and attempting sexual intercourse at least 4 times per month during the 3 months prior to screening.
- •Willing and able to attempt sexual intercourse at least once per week during the study.
- •Judged by the Investigator to be in good general health other than ED.
- •Creatinine clearance (CrCl) >80 mL/min as calculated by Cockcroft-Gault.
- •Able and willing to comply with all study procedures, including use of eDiary/ePRO tools and adherence to dosing instructions.
排除标准
- •Use of nitrates or nitric oxide donors in any form.
- •Use of prohibited antihypertensive medications as defined in the protocol.
- •Use of phosphodiesterase type 5 (PDE5) inhibitors within 5 days prior to baseline.
- •Use of CYP450 inhibitors within 14 days prior to first dose.
- •Use of CYP450 inducers or St. John's Wort within 28 days prior to first dose.
- •Use of any prescription or non-prescription medications, herbal products, or dietary supplements not approved by the Investigator during the required restriction period.
- •Known hypersensitivity to sildenafil, tadalafil, vardenafil, peppermint oil, or any component of the investigational product.
- •Clinically significant abnormalities in screening laboratory tests, vital signs, or electrocardiograms, as judged by the Investigator.
- •Any hepatic impairment or abnormal liver function test results at screening.
- •Positive screening test for hepatitis B surface antigen, hepatitis C antibody, or HIV.
- •Clinically significant illness within 30 days prior to the first dose.
- •Significant cardiovascular disease, including recent myocardial infarction, unstable angina, uncontrolled hypertension, or severe arrhythmias.
- •History of stroke or neurological disorder that may affect sexual function.
- •Severe psychiatric disorder or substance abuse that may interfere with study participation.
- •Anatomical penile deformity (such as Peyronie's disease) that may interfere with erectile function assessments.
- •Positive urine drug screen for amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine (PCP), or MDMA.
- •Alcohol consumption exceeding 15 units per week.
- •Initiation of new nicotine products during the study period.
- •Participation in another clinical trial (other than Hezkue/Hezkue Turbo studies) within 30 days prior to screening.
- •Blood donation or significant blood loss within 3 months prior to screening, or plasma donation within 14 days prior to screening.
- •Major surgery within 3 months or minor surgery within 1 month before screening.
- •Consumption of Seville oranges, grapefruit, or pomelo within 7 days before dosing.
- •Resting systolic blood pressure outside 90-140 mmHg, diastolic blood pressure outside 50-90 mmHg, or heart rate outside 50-100 beats per minute at screening.
- •Sexual partner is pregnant or unwilling to use effective contraception during the study.
- •Any condition that, in the Investigator's opinion, would make the participant unsuitable for the study.
- •Institutionalized individuals.
研究组 & 干预措施
Hezkue
Participants receive Hezkue®, an oral liquid formulation of sildenafil, used on an on-demand basis for 12 weeks.
干预措施: Hezkue (Drug)
Hezkue Turbo
Participants receive Hezkue Turbo®, an oral liquid suspension delivering sildenafil via a metered-dose device, used on an on-demand basis for 12 weeks.
干预措施: Hezkue Turbo (Drug)
Galotam
Participants receive Galotam®, a commercially available sildenafil product, used on an on-demand basis for 12 weeks.
干预措施: Galotam (Drug)
BlueChew
Participants receive BlueChew® sildenafil chewable tablets, used on an on-demand basis for 12 weeks.
干预措施: BlueChew (Drug)
Pfizer Viagra
Participants receive Pfizer Viagra®, a standard oral tablet formulation of sildenafil, used on an on-demand basis for 12 weeks.
干预措施: Pfizer Viagra (Drug)
Aristo Sildaristo
Participants receive Aristo Sildaristo®, a commercially available sildenafil tablet product, used on an on-demand basis for 12 weeks.
干预措施: Aristo Sildaristo (Drug)
Lemonaid Health Viagra
Participants receive Lemonaid Health-branded sildenafil (Viagra), used on an on-demand basis for 12 weeks.
干预措施: Lemonaid Health Sildenafil (Drug)
Ro Sparks
Participants receive Ro Sparks®, a combination sildenafil + tadalafil product, used on an on-demand basis for 12 weeks.
干预措施: Ro Sparks (Drug)
Hims Hard Mints
Participants receive Hims Hard Mints®, a combination sildenafil + tadalafil formulation, used on an on-demand basis for 12 weeks.
干预措施: Hims Hard Mints (Drug)
Hello Cake ED Cake Meds
Participants receive Hello Cake ED Cake Meds®, a combination sildenafil + tadalafil formulation, used on an on-demand basis for 12 weeks.
干预措施: Hello Cake ED Cake Meds (Drug)
结局指标
主要结局
Change From Baseline in IIEF-EF Domain Score
时间窗: Baseline to Week 12
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.
次要结局
- SEP-Q2 Penetration Success Rate(Weeks 0-12)
- SEP-Q3 Intercourse Success Rate(Weeks 0-12)
- Erection Hardness Score (EHS)(Weeks 4, 8, and 12)
- Global Assessment Question (GAQ)(Week 12)
- Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Total Score(Week 12)
- TSQM-II Scores (Effectiveness, Side Effects, Convenience, Global Satisfaction)(Week 12)
- Time-to-Onset of Effect(Weeks 0-12)
- Duration of Effect(Weeks 0-12)
- Incidence of Adverse Events (AEs) and Serious AEs (SAEs)(Screening through Week 13)