Eroxon + Tadalafil for Diabetes
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use Eroxon® gel in conjunction with tadalafil over a 12-week period
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants assigned to this arm will continue to use tadalafil as prescribed per standard of care treatment and will also be instructed to use Eroxon® gel prior to each sexual encounter throughout the 12-week study period.
Participants assigned to this arm will continue their standard-of-care treatment with tadalafil as prescribed. No study-specific changes will be made to their routine clinical management.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Sexual Medicine Society of North America Inc.
Collaborator
Citations
1.
researchgate.net
researchgate.net/publication/8525560_The_efficacy_and_safety_of_tadalafil_An_updateThe 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 ...
4.
globalrx.com
globalrx.com/articles?article=eroxon-fast-acting-topical-gel-profile&product_id=139452Clinical 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.
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