An interventional study of Tamsulosin 0.4 mg + Tadalafil 2.5 mg and Tamsulosin 0.4 mg + Tadalafil 5 mg in Safety, Efficacy and Tamsulosin, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
Among 22 studies testing tamsulosin in Lower Urinary Tract Symptoms — 5 open to participants now, 5 under way, none of them phase 3. Tamsulosin · Lower Urinary Tract Symptoms.
Among the 22 studies testing tamsulosin in Lower Urinary Tract Symptoms, this one is the 13th largest by planned enrollment, is one of 3 that started in 2026, is one of 4 with no phase, and was the 22nd registered.
416 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 272 interventional studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →5 of the 22 studies testing tamsulosin in Lower Urinary Tract Symptoms are open now, in 4 countries. Each count lists the studies.
Tamsulosin: first FDA approval 1997 (FLOMAX). What it is approved for, and how studies give it, is on its page →
Of the 59 Lower Urinary Tract Symptoms studies recruiting now, 39 (66%) set no upper age limit and 11 (19%) stop at 75 or younger; 7 take children under 18; 11 take healthy volunteers.
This study: 45 Years and older · all sexes · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 3 started in 2026.
Median enrollment 136 across the 22 interventional studies. Of the 17 that completed or were terminated, 8 (47%) have results posted.
9 of 22 have an industry lead sponsor. The 10 most frequent:
Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Ain Shams University has 4 studies filed under Lower Urinary Tract Symptoms — fewer than ten, so there is no comparison to draw.
1 of the studies testing tamsulosin in Lower Urinary Tract Symptoms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07722884Ain Shams UniversityTamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH | 2027-01-01 |
Among the 22 studies testing tamsulosin in Lower Urinary Tract Symptoms, from their registry updates:
Nothing recorded among them since 2026-09-25.
This study aims to evaluate the short-term impact and clinical outcomes of tamsulosin monotherapy versus combination therapy with tamsulosin plus tadalafil (2.5 mg vs. 5 mg) on lower urinary tract symptoms (LUTS) severity and patient quality of life in men with benign prostatic hyperplasia (BPH). It also seeks to determine whether the lower tadalafil dose provides adequate symptom relief while minimizing adverse effects over a 12-week follow-up period.
Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) are a fundamental component of modern urology, affecting extensively aging men and significantly impacting their quality of life.
Tamsulosin monotherapy, is effective in the management of BPH by acting as an α₁-adrenergic receptor antagonist that relaxes smooth muscle in the prostate and bladder neck, thereby improving urinary flow and reducing LUTS.
The combination of tamsulosin 0.4 mg with tadalafil is commonly used as an effective option. It balances sufficient symptom relief with moderate side effect profile.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 2.5 mg once daily
Drug: Tamsulosin 0.4 mg + Tadalafil 2.5 mg
Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 5 mg once daily
Drug: Tamsulosin 0.4 mg + Tadalafil 5 mg
Patients will receive Tamsulosin 0.4 mg once daily (monotherapy)
Drug: Tamsulosin 0.4 mg
Drug page: Tamsulosin
Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 2.5 mg once daily
Drug page: Tamsulosin
Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 5 mg once daily
Patients will receive Tamsulosin 0.4 mg once daily (monotherapy)
Mean change in International Prostate Symptom Score (IPSS) score
The International Prostate Symptom Score (IPSS) is an 8-question survey used to evaluate and track the severity of lower urinary tract symptoms, often linked to an enlarged prostate (BPH). Scores range from 0 to 35 based on symptom frequency, with a higher number indicating greater severity. The score evaluates symptoms into the following categories: 0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms
Time frame: 12 weeks post-procedure
Incidence of adverse events
Incidence of adverse events related to Tamsulosin such as dizziness, orthostatic hypotension, headache, fatigue, nasal congestion, retrograde ejaculation, and gastrointestinal disturbances will be recorded.
Time frame: 12 weeks post-procedure
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: After the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jan 2027, 6 months after the start.
Of 98 non-industry interventional studies with no phase under Lower Urinary Tract Symptoms, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 6 months is below that.
Counting every sponsor, half of 119 studies reached it within 27 months; a quarter within 11 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Tamsulosin
Lower Urinary Tract Symptoms →