MED3000 Gel + Tadalafil for Erectile Dysfunction

No longer recruiting at 19 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for erectile dysfunction (ED): a topical gel called MED3000 and a daily tablet called tadalafil. The aim is to evaluate how effectively each treatment improves ED symptoms. Men with mild to severe ED for over three months who are in a stable relationship might be suitable candidates for this trial. Participants will randomly use either the gel or the tablet for up to 30 weeks. As a Phase 3 trial, this study is the final step before FDA approval, providing participants an opportunity to contribute to the availability of new ED treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that MED3000 is safe for treating erectile dysfunction. Research indicates that patients with varying levels of the condition tolerate it well. No major safety issues have been reported so far.

Tadalafil, also known as Cialis, offers another treatment option. It has been used for erectile dysfunction for a long time. Studies have found that the 5 mg dose of tadalafil is safe and well-tolerated by most men. Even with daily use over long periods, it has not shown any major safety concerns.

Both treatments appear safe based on existing research, which should reassure anyone considering joining a trial involving these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about MED3000 and Tadalafil for treating erectile dysfunction because they offer distinct advantages over existing options like Viagra and Cialis. MED3000 is unique because it's a gel applied topically, potentially providing faster onset of action compared to oral medications. Tadalafil, while already a known oral medication, is being explored at a lower dose of 5 mg, which may offer effective results with fewer side effects. Both treatments aim to enhance convenience and reduce the wait time for effectiveness, making them appealing alternatives in the management of erectile dysfunction.

What evidence suggests that this trial's treatments could be effective for erectile dysfunction?

This trial will compare MED3000 gel and Tadalafil 5mg for treating erectile dysfunction. Studies have shown that tadalafil, a common medication for erectile dysfunction (ED), significantly improves erectile function. About 40% of patients regained normal function after using it daily for one year. Another study found that men taking tadalafil had better erections and were more satisfied compared to those taking a placebo, a pill with no active ingredients.

For MED3000 gel, which participants in this trial may receive, early research shows promising results in improving erectile function. The gel is applied directly to the skin, which some people find convenient. Surveys suggest it may enhance sexual experiences for both men and their partners. ^{1 3 6 7 8}

Who Is on the Research Team?

Arthur Burnett, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MED3000
• Tadalafil 5mg

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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, 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 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]

Citations

1. auajournals.org auajournals.org/doi/10.1097/01.JU.0001009412.04863.1b.07

PD52-07 EFFICACY AND SAFETY OF MED3000, A ... Oral phosphodiesterase type 5 (PDE5) inhibitors changed the management of erectile dysfunction (ED) for many men, but they are contraindicated ...

2. academic.oup.com academic.oup.com/jsm/article/21/Supplement_7/qdae167.144/7918951

(147) TOPICAL ADMINISTRATION OF MED3000 GEL ... Erectile dysfunction (ED) negatively impacts self-esteem, confidence, relationships, and quality of life while effective treatment of ED improves these measures ...

3. haleonhealthpartner.com haleonhealthpartner.com/content/dam/cf-consumer-healthcare/health-professionals/en_US/pdf/sexual-health/AUA_Presentation_Efficacy.pdf

Efficacy and safety of MED3000, a novel topical therapy for ... New hypothesis – drug-free control. (MED3000) could help to improve erectile ... ED, erectile dysfunction; IIEF-EF, International Index of Erectile Function ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04984993

Clinical Investigation Using MED3000 Gel or Tadalafil ... An open-label investigation using MED3000 gel or tadalafil (5 mg) tablets in the treatment of erectile dysfunction in patients from 22 to 70 years of age.

5. urologytimes.com urologytimes.com/view/med3000-gel-favorable-responses-seen-on-sexual-encounter-questionnaire

MED3000 gel: Favorable responses seen on sexual ... Use of the topical MED3000 gel for erectile dysfunction appears to confer benefits for both men and their partners, according to Sexual Encounter Profile (SEP) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11439796/

Emergence of Novel Mechanisms in Erectile Dysfunction ... Clinical trials, such as FM57 and FM71, have demonstrated the efficacy and safety of MED3000 in treating erectile dysfunction across different severities [2,3].

7. academic.oup.com academic.oup.com/jsm/article/20/Supplement_4/qdad062.118/7220318

(314) MED3000, A CLINICALLY PROVEN, FAST-ACTING ... ... ERECTILE DYSFUNCTION WITH THE PROSPECT OF BEING THE FIRST GLOBALLY AVAILABLE OTC TREATMENT FOR ED Free. Ralph Dr. David,. Ralph Dr. David.

8. auajournals.org auajournals.org/doi/pdf/10.1097/01.JU.0001009412.04863.1b.07

PD52-07 EFFICACY AND SAFETY OF MED3000, A ... INTRODUCTION AND OBJECTIVE: Oral phosphodiesterase type 5 (PDE5) inhibitors changed the management of erectile dysfunction (ED) for many men, but they are ...