Clinical trial · Interventional
Mirabegron for Treatment of Erectile Dysfunction in Patients With LUTS Secondry to BPH: A Randomized Study
NCT03600766CI-TRIAL-00040396unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To study the impact of mirabegron, a B3-adrenoceptor agonist, in the treatment of ED in patients with LUTS secondary to BPH and concomitant ED.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BPH | Benign Prostatic Hyperplasia | ALIAS | 0.90 |
| Erectile Abnormalities | — | UNRESOLVED | — |
| Erectile Dysfunction | — | UNRESOLVED | — |
| Prostate Hyperplasia | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mirabegron | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Mirabegron
- description
- oral mirabegron 50 gm plus tamsulosin 0.4 mg once daily for 8 weeks
- interventionNames
- Drug: Mirabegron
- type
- ACTIVE_COMPARATOR
- label
- Placebo
- description
- oral toltordine 4 mg plus tamsulosin 0.4 mg daily for 8 weeks.
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- assess change erectile function
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with concomitant ED and irritative LUTS secondary to BPH * Married and sexually motivated. Exclusion Criteria: * Men with Peyronie's disease. * Patients with contraindication to receive mirabegron (High PVR). * Psychiatric disorders. * Previous pelvic surgery or trauma * Men with prostatic adenocarcinoma * Patients refusing participating in the study
References
Publications (0)
Data not yet available
No reference posted for this study.