Erectile DysfunctionPhase 2NCT07231185
Phase 2 Efficacy Study of Sildenafil Products in Adult Men With Erectile Dysfunction
A Phase 2 study testing Hezkue, Hezkue Turbo and Galotam in people with Erectile Dysfunction, run by Aspargo Labs, Inc.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Hezkue, Hezkue Turbo and Galotam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Avi Berg contact
About this study
Official title: 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)
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?
Read more
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
Read the detailed description
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.
- Conditions
- Erectile Dysfunction
- Being tested
- Hezkue, Hezkue Turbo, Galotam, BlueChew, Pfizer Viagra
- Keywords
- erectile dysfunction, Viagra, sildenafil
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HezkueDrug
Also called Sildenafil oral spray
Hezkue® is an oral liquid formulation of sildenafil administered on an on-demand basis for the treatment period.
Hezkue TurboDrug
Also called Sildenafil liquid suspension
Hezkue Turbo® is an oral liquid suspension of sildenafil delivered via a metered-dose device, used on an on-demand basis.
GalotamDrug
Also called Sildenafil tablet (Galotam)
Galotam® is a commercially available sildenafil product administered on an on-demand basis.
BlueChewDrug
Also called Sildenafil chewable tablet
BlueChew® sildenafil chewable tablets, used on an on-demand basis.
Pfizer ViagraDrug
Also called Sildenafil citrate
Pfizer Viagra® sildenafil tablets, administered on an on-demand basis.
Aristo SildaristoDrug
Also called Sildenafil
Aristo Sildaristo® is a commercially available sildenafil tablet product used on an on-demand basis.
Lemonaid Health SildenafilDrug
Also called Sildenafil (Lemonaid Health)
Lemonaid Health-branded sildenafil tablets (Viagra equivalent), administered on an on-demand basis.
Ro SparksDrug
Also called Sildenafil + Tadalafil (Ro Sparks)
Ro Sparks® is a combination sildenafil + tadalafil product administered on an on-demand basis.
Hims Hard MintsDrug
Also called Sildenafil + Tadalafil (Hims)
Hims Hard Mints® is a combination formulation containing sildenafil + tadalafil, used on an on-demand basis.
Hello Cake ED Cake MedsDrug
Also called Sildenafil + Tadalafil (Hello Cake)
Hello Cake ED Cake Meds® is a combination sildenafil + tadalafil product administered on an on-demand basis.
| Study group | Role | What they receive |
|---|---|---|
| Hezkue | Experimental | Participants receive Hezkue®, an oral liquid formulation of sildenafil, used on an on-demand basis for 12 weeks. Receives: Drug: Hezkue |
| Hezkue Turbo | Experimental | Participants receive Hezkue Turbo®, an oral liquid suspension delivering sildenafil via a metered-dose device, used on an on-demand basis for 12 weeks. Receives: Drug: Hezkue Turbo |
| Galotam | Active comparator | Participants receive Galotam®, a commercially available sildenafil product, used on an on-demand basis for 12 weeks. Receives: Drug: Galotam |
| BlueChew | Active comparator | Participants receive BlueChew® sildenafil chewable tablets, used on an on-demand basis for 12 weeks. Receives: Drug: BlueChew |
| Pfizer Viagra | Active comparator | Participants receive Pfizer Viagra®, a standard oral tablet formulation of sildenafil, used on an on-demand basis for 12 weeks. Receives: Drug: Pfizer Viagra |
| Aristo Sildaristo | Active comparator | Participants receive Aristo Sildaristo®, a commercially available sildenafil tablet product, used on an on-demand basis for 12 weeks. Receives: Drug: Aristo Sildaristo |
| Lemonaid Health Viagra | Active comparator | Participants receive Lemonaid Health-branded sildenafil (Viagra), used on an on-demand basis for 12 weeks. Receives: Drug: Lemonaid Health Sildenafil |
| Ro Sparks | Active comparator | Participants receive Ro Sparks®, a combination sildenafil + tadalafil product, used on an on-demand basis for 12 weeks. Receives: Drug: Ro Sparks |
| Hims Hard Mints | Active comparator | Participants receive Hims Hard Mints®, a combination sildenafil + tadalafil formulation, used on an on-demand basis for 12 weeks. Receives: Drug: Hims Hard Mints |
| Hello Cake ED Cake Meds | Active comparator | Participants receive Hello Cake ED Cake Meds®, a combination sildenafil + tadalafil formulation, used on an on-demand basis for 12 weeks. Receives: Drug: Hello Cake ED Cake Meds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (9)
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.
Measured: 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
Measured: Weeks 0-12
Erection Hardness Score (EHS)
Proportion of participants achieving an EHS ≥3 and ≥4 at Weeks 4, 8, and 12.
Measured: Weeks 4, 8, and 12
Global Assessment Question (GAQ)
Proportion of participants responding "Yes" to the GAQ ("Has the treatment improved your erections?").
Measured: Week 12
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Total Score
Participant-reported satisfaction with erectile dysfunction treatment measured using the EDITS questionnaire.
Measured: 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).
Measured: 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.
Measured: Weeks 0-12
Duration of Effect
Participant-reported duration (in hours) of erectile effect after dosing, recorded via eDiary.
Measured: 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.
Measured: Screening through Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study startJan 2026 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Aspargo Labs, IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aspargo Labs, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario Guralnik, PhD, Study director, Aspargo Labs, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231185
- Sponsor's protocol ID
- ASP-011-SIL
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07231185
- Acronym / sponsor ID
- ASP-011-SIL
- Conditions
- Erectile Dysfunction
- Keywords
- erectile dysfunction, Viagra, sildenafil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aspargo Labs, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Hezkue | Experimental | Drug: HezkueParticipants receive Hezkue®, an oral liquid formulation of sildenafil, used on an on-demand basis for 12 weeks. |
| Hezkue Turbo | Experimental | Drug: Hezkue TurboParticipants receive Hezkue Turbo®, an oral liquid suspension delivering sildenafil via a metered-dose device, used on an on-demand basis for 12 weeks. |
| Galotam | Active comparator | Drug: GalotamParticipants receive Galotam®, a commercially available sildenafil product, used on an on-demand basis for 12 weeks. |
| BlueChew | Active comparator | Drug: BlueChewParticipants receive BlueChew® sildenafil chewable tablets, used on an on-demand basis for 12 weeks. |
| Pfizer Viagra | Active comparator | Drug: Pfizer ViagraParticipants receive Pfizer Viagra®, a standard oral tablet formulation of sildenafil, used on an on-demand basis for 12 weeks. |
| Aristo Sildaristo | Active comparator | Drug: Aristo SildaristoParticipants receive Aristo Sildaristo®, a commercially available sildenafil tablet product, used on an on-demand basis for 12 weeks. |
| Lemonaid Health Viagra | Active comparator | Drug: Lemonaid Health SildenafilParticipants receive Lemonaid Health-branded sildenafil (Viagra), used on an on-demand basis for 12 weeks. |
| Ro Sparks | Active comparator | Drug: Ro SparksParticipants receive Ro Sparks®, a combination sildenafil + tadalafil product, used on an on-demand basis for 12 weeks. |
| Hims Hard Mints | Active comparator | Drug: Hims Hard MintsParticipants receive Hims Hard Mints®, a combination sildenafil + tadalafil formulation, used on an on-demand basis for 12 weeks. |
| Hello Cake ED Cake Meds | Active comparator | Drug: Hello Cake ED Cake MedsParticipants receive Hello Cake ED Cake Meds®, a combination sildenafil + tadalafil formulation, used on an on-demand basis for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HezkueAlso: Sildenafil oral sprayHezkue® is an oral liquid formulation of sildenafil administered on an on-demand basis for the treatment period. | Drug | Hezkue |
| Hezkue TurboAlso: Sildenafil liquid suspensionHezkue Turbo® is an oral liquid suspension of sildenafil delivered via a metered-dose device, used on an on-demand basis. | Drug | Hezkue Turbo |
| GalotamAlso: Sildenafil tablet (Galotam)Galotam® is a commercially available sildenafil product administered on an on-demand basis. | Drug | Galotam |
| BlueChewAlso: Sildenafil chewable tabletBlueChew® sildenafil chewable tablets, used on an on-demand basis. | Drug | BlueChew |
| Pfizer ViagraAlso: Sildenafil citratePfizer Viagra® sildenafil tablets, administered on an on-demand basis. | Drug | Pfizer Viagra |
| Aristo SildaristoAlso: SildenafilAristo Sildaristo® is a commercially available sildenafil tablet product used on an on-demand basis. | Drug | Aristo Sildaristo |
| Lemonaid Health SildenafilAlso: Sildenafil (Lemonaid Health)Lemonaid Health-branded sildenafil tablets (Viagra equivalent), administered on an on-demand basis. | Drug | Lemonaid Health Viagra |
| Ro SparksAlso: Sildenafil + Tadalafil (Ro Sparks)Ro Sparks® is a combination sildenafil + tadalafil product administered on an on-demand basis. | Drug | Ro Sparks |
| Hims Hard MintsAlso: Sildenafil + Tadalafil (Hims)Hims Hard Mints® is a combination formulation containing sildenafil + tadalafil, used on an on-demand basis. | Drug | Hims Hard Mints |
| Hello Cake ED Cake MedsAlso: Sildenafil + Tadalafil (Hello Cake)Hello Cake ED Cake Meds® is a combination sildenafil + tadalafil product administered on an on-demand basis. | Drug | Hello Cake ED Cake Meds |
Primary outcome
Change From Baseline in IIEF-EF Domain Score
Time frame: 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.
9 secondary outcomes
SEP-Q2 Penetration Success Rate
Time frame: Weeks 0-12
SEP-Q3 Intercourse Success Rate
Time frame: Weeks 0-12
Erection Hardness Score (EHS)
Time frame: Weeks 4, 8, and 12
Global Assessment Question (GAQ)
Time frame: Week 12
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Total Score
Time frame: Week 12
TSQM-II Scores (Effectiveness, Side Effects, Convenience, Global Satisfaction)
Time frame: Week 12
Time-to-Onset of Effect
Time frame: Weeks 0-12
Duration of Effect
Time frame: Weeks 0-12
Incidence of Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Screening through Week 13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Avi Berg contact
Mario Guralnik, PhD study director
Aspargo Labs, Inc
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hezkue, Hezkue Turbo and Galotam in people with Erectile Dysfunction, run by Aspargo Labs, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Guralnik, PhD (17189381157, avi.berg@synergy-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in IIEF-EF Domain Score (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.