Eroxon + Tadalafil for Diabetes

AG
Overseen ByAshley Gray
Age: 18 - 65
Sex: Male
Trial Phase: Phase 4
Sponsor: University of Miami
Must be taking: Tadalafil
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using Eroxon® gel with tadalafil (a medication for erectile dysfunction) can improve erectile function in men with type 2 diabetes. Participants will either use both the gel and tadalafil or only tadalafil as usual. It is ideal for men aged 18 to 40 who have type 2 diabetes, experience erectile dysfunction, and are already taking tadalafil. Participants need a willing sexual partner to complete a survey. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients.

What is the safety track record for Eroxon® and tadalafil?

A previous study showed that tadalafil improved erections in 56% to 64% of men with diabetes, depending on the dose, compared to 25% for those taking a placebo. Most side effects were mild or moderate, with no serious issues reported. Another study found that serious heart problems with tadalafil were rare and similar to those in people taking a placebo. Long-term use of Eroxon gel demonstrated its safety, with only minor side effects. Overall, these findings suggest that both treatments are generally well-tolerated and safe.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combination of Eroxon® gel with tadalafil for diabetes-related erectile dysfunction because it introduces a novel topical approach to enhancing the efficacy of an existing oral treatment. Unlike standard options that rely solely on oral medications like tadalafil, this combination uses Eroxon® gel, a topical treatment that can be applied directly before sexual activity. This method may offer quicker onset of action and potentially fewer systemic side effects, making it an appealing option for individuals seeking more immediate improvements. By targeting the condition both systemically and locally, this combination has the potential to enhance overall treatment effectiveness and satisfaction.

What evidence suggests that Eroxon® gel combined with tadalafil might be an effective treatment for erectile dysfunction in men with type 2 diabetes?

Research has shown that Eroxon gel might improve erectile function by increasing blood flow to the penis. Although few studies focus specifically on Eroxon gel for men with diabetes, it functions similarly to other topical treatments that have demonstrated positive results. Tadalafil is well-known for aiding men, including those with diabetes, in improving erectile function. It relaxes muscles and increases blood flow to help achieve and maintain an erection. This trial will compare two groups: one group will use both Eroxon gel and tadalafil, while the other will use tadalafil alone. Researchers aim to determine whether combining Eroxon gel with tadalafil enhances erectile function more than using tadalafil alone.

Who Is on the Research Team?

SK

Sonjia Kenya, E.D

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for men aged 18 to 40 who have type 2 diabetes and are experiencing erectile dysfunction. Participants should generally be in stable health aside from their diabetes.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.
My sexual partner is willing to complete a survey.
I was assigned male at birth.
See 4 more

Exclusion Criteria

I use nitrate medications or cannot safely have sexual activity.
Known allergy to Eroxon® gel components
Participation in another interventional sexual health study
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use Eroxon® gel in conjunction with tadalafil over a 12-week period

12 weeks
Regular visits as per standard of care

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Eroxon®
  • tadalafil

Trial Overview

The study is testing whether using Eroxon® gel together with tadalafil can improve erections in men with type 2 diabetes. The effects of this combination will be compared to standard treatments.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Standard of Care (Tadalafil) + Eroxon® Gel GroupExperimental Treatment2 Interventions
Group II: Tadalafil (Control) GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Sexual Medicine Society of North America Inc.

Collaborator

Citations

The efficacy and safety of tadalafil: An update | Request PDF

In a study with 191 diabetic men tadalafil 10 and 20 mg on demand resulted in 56% and 64% improvement of their erections compared to 25% in the placebo arm

Diabetes, Obesity and Erectile Dysfunction: Field Overview ...

The article discusses the relationship between diabetes, obesity, and erectile dysfunction (ED), highlighting the importance of ...

Comparison of the efficacy and safety of once-daily dosing ...

All included studies indicated that most adverse events were mild or moderate in severity, and no serious adverse events were reported during ...

Clinical Profile of Eroxon Fast Acting Topical Gel

A long-term follow-up study also confirmed the gel's safety profile with minimal side effects reported over extended use.

Effect of Low-Dose Tadalafil Once Daily On Glycemic ...

causing major adverse health outcomes such as dyslipidemia, type 2 diabetes mellitus, cardiovascular disease and cancers.