New ED drugs hezkue and hezkue turbo face off against Viagra-Like pills
NCT ID NCT07231185
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two new erectile dysfunction (ED) treatments, Hezkue and Hezkue Turbo, against several standard sildenafil products. About 200 men with ED will use one of the assigned treatments as needed for 12 weeks. Researchers will measure improvements in erectile function, sexual success rates, and any side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 ≤25. 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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