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Phase 2 Efficacy Study of Sildenafil Products in Adult Men With Erectile Dysfunction

ConditionErectile Dysfunction
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-70
SponsorAspargo Labs, Inc

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male, 18 to 70 years of age.

Disqualifiers

Use of nitrates or nitric oxide donors in any form.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hezkue

    Drug

    Hezkue® is an oral liquid formulation of sildenafil administered on an on-demand basis for the treatment period.

  • Hezkue Turbo

    Drug

    Hezkue Turbo® is an oral liquid suspension of sildenafil delivered via a metered-dose device, used on an on-demand basis.

  • Galotam

    Drug

    Galotam® is a commercially available sildenafil product administered on an on-demand basis.

  • BlueChew

    Drug

    BlueChew® sildenafil chewable tablets, used on an on-demand basis.

  • Pfizer Viagra

    Drug

    Pfizer Viagra® sildenafil tablets, administered on an on-demand basis.

  • Aristo Sildaristo

    Drug

    Aristo Sildaristo® is a commercially available sildenafil tablet product used on an on-demand basis.

  • Lemonaid Health Sildenafil

    Drug

    Lemonaid Health-branded sildenafil tablets (Viagra equivalent), administered on an on-demand basis.

  • Ro Sparks

    Drug

    Ro Sparks® is a combination sildenafil + tadalafil product administered on an on-demand basis.

  • Hims Hard Mints

    Drug

    Hims Hard Mints® is a combination formulation containing sildenafil + tadalafil, used on an on-demand basis.

  • Hello Cake ED Cake Meds

    Drug

    Hello Cake ED Cake Meds® is a combination sildenafil + tadalafil product administered on an on-demand basis.

Treatment groups

200 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: HezkueExperimental treatment 1 intervention
Group B: Hezkue TurboExperimental treatment 1 intervention
Group C: GalotamActive comparator 1 intervention
Group D: BlueChewActive comparator 1 intervention
Group E: Pfizer ViagraActive comparator 1 intervention
Group F: Aristo SildaristoActive comparator 1 intervention
Group G: Lemonaid Health ViagraActive comparator 1 intervention
Group H: Ro SparksActive comparator 1 intervention
Group I: Hims Hard MintsActive comparator 1 intervention
Group J: Hello Cake ED Cake MedsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

Global Assessment Question (GAQ)

Proportion of participants responding "Yes" to the GAQ ("Has the treatment improved your erections?").

Time frame
Week 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aspargo Labs, Inc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: