Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms Health Condition 2: N529- Male erectile dysfunction, unspecified
Conditions
Interventions
Intervention1: FDC of Silodosin 8 mg and Tadalafil Capsule 5 mg: One capsule, once daily with meal, preferably at the same time for 12 weeks
Control Intervention1: Tadalafil Tablets 5 mg: One tablet,
Sponsors
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male patient, aged 50 to 75 years (both inclusive) 2) Patient who is already on alpha (a)-blockers for BPH OR Phosphodiesterase 5 inhibitors (PDE5Is) for BPH and ED 3) Patient having total International Prostate Symptom Score (IPSS) score = 13 4) Patient with maximum urinary flow rate (Qmax) of 4 to 15 mL/second (both inclusive) and minimum voided volume = 125 mL at the time of randomization 5) Patient with Post-void residual (PVR) volume 6) Patient with International Index of Erectile Function - Erectile Function Domain (IIEF-EF) of = 25 at the time of randomization 7) Patient is willing to give informed consent, able to swallow study medications and follow study protocol.
Exclusion criteria
Exclusion criteria: 1) Patient with prostate specific antigen (PSA) = 4 ng/mL at screening and randomization. 2) Patient with history of neurologic bladder, urethral strictures, urinary tract infections, urologic cancer, and prostatic surgery 3) Patient with clinically significant bladder outflow obstruction other than BPH (calculi, tumor or stricture), as judged by Investigator 4) Patient undergoing haemodialysis 5) Patient with moderate to severe renal impairment (Creatinine clearance 6) Clinical evidence of any other active bladder or urinary tract conditions, which may affect lower urinary tract symptom at screening. 7) Current or past history of symptomatic orthostatic hypotension or recurrent dizziness, vertigo, loss of consciousness or syncope. 8) Patient having hypersensitivity or any other contraindication to any of the Investigational products including its components. 9) Patient with blood pressure (BP) = 140/90 mm of Hg or Glycosylated hemoglobin (HbA1c) ? 9%. 10) Patient has a clinically significant disorder that (for ex. Patient who is likely to require catheterization within next 3 months, unable to take oral medications), in the opinion of the investigator, would result in the patient’s inability to understand and comply with the requirements of the study 11) Patient with history of Human immunodeficiency virus (HIV) and/or Hepatitis B and/or Hepatitis C. 12) Patient planning cataract surgery during the study 13) Use of any 5-a-reductase inhibitor, any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents), or other drugs which affect prostate volume, within past 3 months prior to screening. 14) Patient on nitrates or beta-agonists within 2 weeks of screening or who are planning to take during the study 15) Patient using strong Cytochrome P4503A4 (CYP4503A4) inhibitors (ketoconazole, clarithromycin, itraconazole, ritonavir etc.), strong P-glycoprotein (P-gp) Inhibitors (for e.g. Ketoconazole) at the time of screening or during study 16) Patient with known alcohol or other substance abuse within last one year as per The Diagnostic and Statistical Manual of Mental Disorders (DSM) – 5 criteria 17) Patient involved in professions like driving, operating heavy machinery or performing hazardous work 18) Patient who have participated in another investigational study within 3 months prior to enrolment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Total IPSS from baseline at the end of Week 12Timepoint: baseline, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in IIEF-EF (questions 1–5 and 15) score from baseline at Weeks 4, 8 and 12Timepoint: Baseline, Weeks 4, 8 and 12;Change in IPSS Quality of life (IPSS-QoL) from baseline at Weeks 4, 8 and 12Timepoint: Baseline, Weeks 4, 8 and 12;Change in IPSS storage (Irritative) subscore from baseline at Weeks 4, 8 and 12Timepoint: Baseline, Weeks 4, 8 and 12;Change in IPSS voiding (Obstructive) subscore from baseline at Weeks 4, 8 and 12Timepoint: Baseline, Weeks 4, 8 and 12;Change in PVR volume from baseline at Weeks 4, 8 and 12Timepoint: Baseline, Weeks 4, 8 and 12;Change in Qmax from baseline at Weeks 4, 8 and 12Timepoint: Baseline, Weeks 4, 8 and 12;Change in Total IPSS from baselineTimepoint: Baseline, Weeks 4 and 8 ;Percentage of participants showing normal erectile function (IIEF-EF score 26) at the end of 12 weeksTimepoint: At the end of 12 weeks;Treatment Emergent Adverse Events (TEAEs) reported during the studyTimepoint: During the study | — |
Countries
India
Contacts
Public ContactSucheta A Pandit
Sun Pharma Laboratories Limited
Outcome results
None listed