Tadalafil for Erectile Dysfunction

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Sanofi

Disqualifiers: Massachusetts, English, Healthcare professional, 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

2250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how effectively individuals can use Cialis, a medication for erectile dysfunction (ED), when available over the counter with instructions and a health survey. Researchers aim to determine if participants can correctly follow the product label and health survey over four months. Men with ED symptoms interested in trying an over-the-counter treatment may qualify for this study. Participants must reside in the U.S., but residents of Massachusetts are excluded due to state laws. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the availability of a new over-the-counter treatment option.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that tadalafil, the main ingredient in Cialis, is generally safe for people. Studies have found that tadalafil is well-tolerated when used for erectile dysfunction. For example, one study found that taking tadalafil in doses of 5, 10, or 20 mg as needed was safe for up to two years.

The FDA has already approved tadalafil for treating erectile dysfunction, which adds confidence about its safety. However, like all medicines, it might have side effects. Common issues include headaches, upset stomach, or muscle pain. These side effects are usually mild and temporary.

Overall, evidence suggests that tadalafil is a safe option for many people. However, it is important to discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard prescription options for erectile dysfunction, like Viagra (sildenafil) and Levitra (vardenafil), the treatment tadalafil is being investigated for potential over-the-counter (OTC) availability. Researchers are excited because this could make tadalafil more accessible to those who need it, eliminating the need for a prescription and potentially reducing barriers to treatment. Additionally, tadalafil is known for its longer duration of action compared to other medications, offering more spontaneity and flexibility for users.

What is the effectiveness track record for Tadalafil in treating erectile dysfunction?

Research has shown that tadalafil effectively treats erectile dysfunction (ED). In one study, 71% to 84% of men reported improved erections after using tadalafil. Another study found that tadalafil significantly enhanced erections in men with mild to severe ED and outperformed a placebo across all levels of ED severity. These findings suggest that tadalafil is a reliable option for improving erectile function. Participants in this trial will receive tadalafil in an open-label, single-arm study to further evaluate its effectiveness as an over-the-counter treatment for ED. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Tadalafil

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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 215 men with erectile dysfunction, 66.3% preferred tadalafil 20 mg over sildenafil 50 mg for initial treatment, indicating a strong patient preference for tadalafil (P < 0.001).

Both tadalafil and sildenafil were well tolerated, with no significant differences in adverse events, suggesting that both medications are safe options for treating erectile dysfunction.

NCBI (Pubmed)

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. Govier, F., Potempa, AJ., Kaufman, J., et al.[2019]

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 phosphodiesterase type 5 inhibitor, is being developed for the treatment of erectile dysfunction and has received marketing approval in Europe as of November 2002.

The drug is expected to launch in both North America and Europe in the first half of 2003, indicating a significant step towards making this treatment available to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tadalafil Lilly ICOS. Rotella, DP.[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, 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 PDE5 inhibitor, shows a significant erectogenic effect starting as early as 16 minutes after taking a 20 mg dose, with 52% of men achieving successful intercourse within 30 minutes compared to 35.1% for placebo.

The study involved a multicenter, randomized, double-blind, placebo-controlled design with men aged 21 and older, demonstrating that both 10 mg and 20 mg doses of tadalafil can lead to effective erections within a short time frame after dosing.

NCBI (Pubmed)

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. Rosen, RC., Padma-Nathan, H., Shabsigh, R., 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2643112/

Tadalafil in the treatment of erectile dysfunction - PMC At the endpoint of the trial using the GAQ, 71% and 84% of patients reported overall improved erections with the two doses of tadalafil, respectively, compared ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0302283804002374

Efficacy and Treatment Satisfaction with On-Demand ... Conclusion: In men with mild-to-severe ED, tadalafil 20 mg significantly improves erectile function, demonstrates superior treatment satisfaction relative to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3735316/

Efficacy and safety of tadalafil taken as needed for the ... Both tadalafil doses showed greater improvements in erectile function than placebo (P < 0.001) for each ED severity level (mild, moderate, or severe ED). In ...

4. jurolsurgery.org jurolsurgery.org/articles/does-the-daily-dose-of-tadalafil-for-the-treatment-of-erectile-dysfunction-increase-penile-sensation/jus.galenos.2022.2022.0042

Does the Daily Dose of Tadalafil for the Treatment ... Conclusion: In this study, we showed that tadalafil at a daily dose of 5 mg used for treating ED provides an increase in penile sensation.

5. academic.oup.com academic.oup.com/jsm/article/21/8/671/7695980

Spontaneous erectile function recovery among young men ... Current real-life findings showed that almost half of young ED patients taking tadalafil 5 mg OaD for 3 months achieved medication-free EF ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK603743/

Tadalafil - StatPearls - NCBI Bookshelf - NIH This drug has received FDA approval for the management of erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and pulmonary arterial ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf

CIALIS (tadalafil) tablets Label - accessdata.fda.gov The safety and efficacy of combinations of CIALIS and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/tadalafil-oral-route/description/drg-20067204

Tadalafil (oral route) - Side effects & dosage When using this medicine for erectile dysfunction, the ability to have sexual activity may be improved for up to 36 hours after taking the tablet. Use only the ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0302283803005852

Long-Term Safety and Tolerability of Tadalafil in the ... Conclusion: Tadalafil at doses of 5, 10, or 20 mg taken as needed up to once daily for 18 to 24 months was safe and well tolerated. These findings support the ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6219303/

Evaluation of the long-term safety and effectiveness of tadalafil ... In addition, approximately 40% of patients regained normal erectile function (IIEF-EF ≥26) following 1 year of tadalafil once-daily treatment. The findings in ...