Tadalafil for Erectile Dysfunction

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Sanofi

Disqualifiers: Massachusetts, English, Healthcare professional, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this actual use trial (AUT) is to evaluate if participants can appropriately select and use the study product \[Cialis over the counter (OTC)\] using the labeling and the mandatory health survey assessment (HSA) for duration of 4-months.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Tadalafil for erectile dysfunction?

Research shows that Tadalafil is effective in improving erectile function and is safe to use, with effects lasting up to 36 hours. It is particularly beneficial for men with erectile dysfunction, even those with conditions like high blood pressure or diabetes. ^{1 2 3 4 5}

Is tadalafil safe for treating erectile dysfunction?

Tadalafil is generally safe for treating erectile dysfunction, with most side effects being mild or moderate and temporary. It does not increase the risk of heart problems and can be safely used with medications for high blood pressure. ^{2 6 7 8 9}

How is the drug Tadalafil unique for treating erectile dysfunction?

Tadalafil is unique because it is an oral medication that can improve erectile function for up to 36 hours, allowing more flexibility in timing sexual activity compared to other treatments. It is also effective for men with erectile dysfunction related to conditions like high blood pressure and diabetes. ^{1 10 11 12 13}

Research Team

Eligibility Criteria

This trial is for individuals experiencing erectile dysfunction. Participants will be using Tadalafil 5 mg tablets along with a digital tool to assess their ability to select and use the medication correctly over a period of four months.

Inclusion Criteria

I am 16 or older and live in the US.

I am a male over 18, completed the HSA with a Cialis purchase code, and bought the product.

Exclusion Criteria

Participant cannot read, speak, and understand English

Participant or someone else in the household is employed by PEGUS Research

I am willing and able to attend the enrollment interview remotely.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Use

Participants use tadalafil 5 mg tablets as an over-the-counter treatment for erectile dysfunction

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tadalafil (Phosphodiesterase Inhibitor)

Trial Overview The study is testing whether men with erectile dysfunction can properly choose and use Tadalafil (Cialis) as an over-the-counter drug, guided by product labeling and a mandatory health survey assessment.

Participant Groups

Group I: Cialis OTC Experimental Treatment 1 Intervention

Open Label Single Arm study in men who have the symptoms of ED and who have an interest in an OTC treatment.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Findings from Research

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]

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 12-month study involving 1,900 men with erectile dysfunction, 84% continued using tadalafil, indicating its effectiveness and patient acceptance as a treatment option.

Patient satisfaction after the first month of tadalafil treatment was the strongest predictor of continued use, highlighting the importance of early treatment response in managing erectile dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of patient expectations and treatment satisfaction after 1-year tadalafil therapy for erectile dysfunction: the DETECT study. Perimenis, P., Roumeguere, T., Heidler, H., et al.[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]

Tadalafil is an effective treatment for erectile dysfunction (ED) with a prolonged action lasting up to 36 hours, making it significantly longer-lasting than other medications like sildenafil, which lasts about 4 hours.

It not only improves erectile function in patients with ED, including those with other health conditions, but also helps restore confidence and normal sexual life, leading to its increasing preference as a first-line therapy among ED patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of tadalafil for erectile dysfunction: an updated review]. Bai, WJ.[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]

In a study of 80 patients with erectile dysfunction, tadalafil significantly improved phallic stiffness and duration of erections, with an overall satisfaction rate of 82.5%.

The treatment was particularly effective for patients with psychogenic erectile dysfunction, showing a 92.3% success rate, while those with organic or mixed causes had lower success rates, indicating that the underlying cause of ED may influence treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Observation of safety and efficacy of tadalafil for men with erectile dysfunction]. Zhu, XW., Li, FY., Fang, JJ.[2015]

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. China pubmed.ncbi.nlm.nih.gov

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

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

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of patient expectations and treatment satisfaction after 1-year tadalafil therapy for erectile dysfunction: the DETECT study. [2015]

4. 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]

5. China pubmed.ncbi.nlm.nih.gov

[Efficacy of tadalafil for erectile dysfunction: an updated review]. [2015]

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

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

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

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

8. China pubmed.ncbi.nlm.nih.gov

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

9. China pubmed.ncbi.nlm.nih.gov

[Observation of safety and efficacy of tadalafil for men with erectile dysfunction]. [2015]

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

A multicenter, randomized, double-blind, crossover study of patient preference for tadalafil 20 mg or sildenafil citrate 50 mg during initiation of treatment for erectile dysfunction. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Determining the earliest time within 30 minutes to erectogenic effect after tadalafil 10 and 20 mg: a multicenter, randomized, double-blind, placebo-controlled, at-home study. [2015]

12. England pubmed.ncbi.nlm.nih.gov

Tadalafil Lilly ICOS. [2015]

13. 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]