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New treatment option for Erectile Dysfunctions
Official title Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients
ClinicalTrials.gov ID: NCT07391579
What this study is testing
What is Tadalafil 5 mg & Sildenafil 100mg?
Tadalafil 5 mg & Sildenafil 100mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for erectile dysfunctions.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate whether daily dosing with tadalafil 5 mg combined with on-demand sildenafil 100 mg can improve erectile function in men with erectile dysfunction (ED) who do not respond to PDE5 inhibitor alone. The main questions it aims to answer are: Does the combination of daily tadalafil and on-demand sildenafil lead to a greater improvement in erectile function (measured by the IIEF-EF domain) compared with on-demand sildenafil alone?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older, men only
You may be able to join if
- Sexually active male.
- History of ED for ≥6 months.
- Erectile function domain of IIEF-15 score \<17.
- Documented failure to respond to PDE-5I [definition of non-responder patients are patients with ED who don't respond to maximum dose of PDE-5I on ≥4...
- Stable sexual relationship ≥ 6 months.
You likely can't join if
- Penile anatomical deformities or Peyronie's disease.
- Pelvic surgery or radiation.
- Active malignancy or severe systemic illness.
- Previous penile surgery of any kind, such as penile prosthesis, penile lengthening, penile cancer surgery, penile plication or grafting.
- Contraindication to PDE5i (High risk cardiac patients, patients on nitrates, hypotension).
- Using other treatments for ED e.g., Intra-cavernoasl prostaglandin injection therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Al Mansurah, Dakahlia Governorate, Egypt
- Alexandria, Egypt
- Aswān, Egypt
- Asyut, Egypt
- Cairo, Egypt
- Luxor, Egypt
- Minya, Egypt
- Tanta, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Al Mansurah, Dakahlia Governorate, Egypt; Alexandria, Egypt; Aswān, Egypt; Asyut, Egypt; Cairo, Egypt; Luxor, Egypt and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.