Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction

Recruiting at 17 trial locations

Overseen By Tim Holland, MBA

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Futura Medical Developments Ltd.

Disqualifiers: Cardiovascular, Pulmonary, Hepatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

116 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two treatments for erectile dysfunction in men aged 22 to 70. One treatment is a gel applied to the skin, and the other is a pill taken orally. Both treatments work by improving blood flow to help achieve and maintain an erection. Participants will use either the gel or the pill for several months.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using any medication that might affect your ability to participate, the Principal Investigator may advise you to stop.

What evidence supports the effectiveness of the drug MED3000 and Tadalafil 5mg?

Research shows that Tadalafil, a component of the treatment, is effective in improving erectile function in men with erectile dysfunction. Studies indicate that Tadalafil significantly enhances erectile function compared to a placebo, with improvements noted in various measures of sexual performance. ^{1 2 3 4 5}

Is tadalafil safe for humans?

Tadalafil, used for erectile dysfunction, is generally safe and well-tolerated in humans. Most side effects are mild or moderate and go away on their own. It is also safe for people with heart conditions and can be taken with blood pressure medications. ^{1 2 6 7 8}

How does the drug MED3000 differ from other erectile dysfunction treatments?

MED3000 is unique because it is a topical gel applied directly to the skin, unlike tadalafil, which is taken orally. This makes MED3000 potentially faster-acting and more convenient for some users compared to traditional oral medications like tadalafil. ^{1 2 9 10 11}

Research Team

Arthur Burnett, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

Male heterosexual patients aged 22-70 years.

Confirmed clinical diagnosis of mild, moderate or severe ED for more than 3 months.

Involved in a continuous heterosexual relationship with their partner for at least 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MED3000 gel or tadalafil (5 mg) tablets for erectile dysfunction treatment

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MED3000
• Tadalafil 5mg

Participant Groups

Group I: Tadalafil Experimental Treatment 2 Interventions

Tadalafil (5 mg) tablets to be taken orally

Group II: MED3000 Experimental Treatment 2 Interventions

MED3000 gel formulation topically applied to the glans penis

Who Is Running the Clinical Trial?

Futura Medical Developments Ltd.

Lead Sponsor

Trials

6

Recruited

1,500+

Findings from Research

In a study involving 2102 men with erectile dysfunction, tadalafil significantly improved erectile function compared to placebo, with mean improvements in the International Index of Erectile Function (IIEF) scores of 6.5 and 8.6 for the 10 mg and 20 mg doses, respectively.

Tadalafil was effective for up to 36 hours after dosing and showed consistent efficacy across different severities and causes of erectile dysfunction, with common side effects including headache and back pain, indicating it is a well-tolerated treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of tadalafil: an update. Carson, CC., Rajfer, J., Eardley, I., et al.[2023]

In a 24-week study involving patients aged 18 and older, tadalafil dosed once daily significantly improved erectile function compared to placebo, as measured by the International Index of Erectile Function and Sexual Encounter Profile responses.

Tadalafil was well tolerated, with a low discontinuation rate due to adverse events (6.3% for 2.5 mg and 4.1% for 5 mg), and common side effects included nasopharyngitis and back pain, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tadalafil dosed once a day in men with erectile dysfunction: a randomized, double-blind, placebo-controlled study in the US. Rajfer, J., Aliotta, PJ., Steidle, CP., et al.[2015]

Tadalafil is an effective oral treatment for erectile dysfunction (ED), with its effects lasting up to 36 hours, giving patients flexibility in timing sexual activities.

It is also beneficial for men with ED related to conditions like hypertension and diabetes, highlighting its broader applicability in treating erectile dysfunction associated with various health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of tadalafil for the treatment of erectile dysfunction]. Liu, ZY., Sun, YH.[2015]

Tadalafil is generally safe and well-tolerated for chronic treatment of erectile dysfunction, even in high-risk populations, with most side effects being mild or moderate and reversible without stopping the medication.

It does not increase the risk of cardiovascular issues and can be safely used alongside antihypertensive medications and selective alpha-receptor blockers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety and tolerance of tadalafil in the treatment of erectile dysfunction]. He, XY.[2015]

Tadalafil, a new oral treatment for erectile dysfunction, is highly effective with a duration of action lasting up to 36 hours, making it a convenient option for patients.

The medication has a strong safety profile, with only a few mild to moderate side effects reported, which is particularly important for patients who may have other medical conditions or take multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Tadalafil for erectile dysfunction: excellent safety and tolerance]. Bai, WJ.[2015]

Tadalafil, a PDE-5 inhibitor, is effective for treating erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia, showing good tolerance in patients.

The drug is considered safe for patients with cardiovascular comorbidities and may even provide beneficial effects on cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety of tadalafil in patients with cardiovascular comorbidities]. Nikitina, IL., Gaysina, GG., Galimov, SN., et al.[2019]

Tadalafil significantly improved erectile function in both patients who had never used sildenafil (naïve patients) and those who had previously responded to sildenafil, indicating its efficacy across different patient backgrounds.

The analysis of 2,789 patients from 14 clinical trials suggests that excluding patients who did not respond to sildenafil in earlier studies may not have greatly influenced the reported efficacy of tadalafil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of tadalafil in men with erectile dysfunction naïve to phosphodiesterase 5 inhibitor therapy compared with prior responders to sildenafil citrate. Broderick, GA., Donatucci, CF., Hatzichristou, D., et al.[2017]

In a study involving 367 South-East Asian men with erectile dysfunction, tadalafil significantly improved erectile function compared to placebo, with mean improvements in the IIEF Erectile Function score of 8.1 for 10 mg and 8.7 for 20 mg doses.

Tadalafil was well-tolerated, with common side effects including headache and back pain, and a high percentage of patients (81% for 10 mg and 86% for 20 mg) reported improved erections, indicating its efficacy and safety in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of on-demand tadalafil for the treatment of erectile dysfunction in South-East Asian men. Guo, YL., Zhu, JC., Pan, TM., et al.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

The efficacy and safety of tadalafil: an update. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Tadalafil dosed once a day in men with erectile dysfunction: a randomized, double-blind, placebo-controlled study in the US. [2015]

3. China pubmed.ncbi.nlm.nih.gov

[Evaluation of tadalafil for the treatment of erectile dysfunction]. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and treatment satisfaction of tadalafil versus placebo in patients with erectile dysfunction evaluated at tertiary-care academic centers. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Effects of tadalafil treatment after bilateral nerve-sparing radical prostatectomy: quality of life, psychosocial outcomes, and treatment satisfaction results from a randomized, placebo-controlled phase IV study. [2018]

6. China pubmed.ncbi.nlm.nih.gov

[Safety and tolerance of tadalafil in the treatment of erectile dysfunction]. [2015]

7. China pubmed.ncbi.nlm.nih.gov

[Tadalafil for erectile dysfunction: excellent safety and tolerance]. [2015]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Safety of tadalafil in patients with cardiovascular comorbidities]. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of tadalafil in men with erectile dysfunction naïve to phosphodiesterase 5 inhibitor therapy compared with prior responders to sildenafil citrate. [2017]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety of on-demand oral tadalafil in the treatment of men with erectile dysfunction in Taiwan: a randomized, double-blind, parallel, placebo-controlled clinical study. [2015]

11. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and safety of on-demand tadalafil for the treatment of erectile dysfunction in South-East Asian men. [2015]