A study of Fixed Dose Combination of Tamsulosin and Tadalafil Capsules to check safety and efficacy in Patients with Benign Prostatic Hyperplasia and Erectile Dysfunction.
- Conditions
- Health Condition 1: N400- Benign prostatic hyperplasia without lower urinary tract symptoms
- Registration Number
- CTRI/2022/06/043152
- Lead Sponsor
- Sun Pharma Laboratory Limited SP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Sexually active male patient, aged between 45 to 75 years (both inclusive), diagnosed with BPH and Erectile dysfunction
2) Patient who is taking both Tamsulosin 0.4 mg and Tadalafil 5 mg concomitantly for BPH and ED at Screening [Note: Patients will undergo a wash out period of 28 days)
3) Patient having total International Prostate Symptom Score (IPSS) score >= 8 (moderate to severe BPH) at the time of enrolment
4) Patient having Qmax between 5 ml/sec and 15 ml/sec (both included) with minimum voided volume of >125 ml at the time of enrolment
5) Patient with PVR volume < 300 mL as assessed by ultrasound at enrolment
6) Patient with International Index of Erectile Function - Erectile Function Domain (IIEF-EF) of <= 25 at the time of enrolment
7) Patient is willing to give informed consent, able to swallow study medications and follow study protocol.
1) Prostate specific antigen (PSA) beyond 4 ng/mL at screening, and enrolment
2) Patient with history of neurologic bladder, urethral strictures, urinary tract infections, prostatitis, 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) Clinical evidence of any other bladder or urinary tract conditions, which may affect lower urinary tract symptom at screening
5) Patient undergoing haemodialysis
6) Patient who are planning for cataract or glaucoma surgery
7) Patients with history of cardiovascular disease (including but not limited to):
- History of myocardial infarction within the last 90 days
- History of angina
- History of Congestive cardiac failure (New York Heart Association Class 2 or higher) in the last 6 months
- Patients with uncontrolled arrhythmias, hypotension (BP <90/60 mm Hg) or uncontrolled hypertension (>=170/100 mmHg)
- History of orthostatic hypotension, or recurrent dizziness, vertigo, loss of consciousness or syncope
- History of stroke within the last 6 months
Known left ventricular outflow tract obstruction (e.g., aortic stenosis and idiopathic hypertrophic subaortic valve stenosis)
- Patients with any other cardiac disease for which sexual activity is not recommended
8) Patient with any other clinically significant disorder that (for e.g. 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 patientâ??s inability to understand and comply with the requirements of the study
9) Patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronies disease)
10) Patients history of priapism with prior use of α1-blocker(s)/PDE-5 inhibitors (or combination of both), or have known condition(s) which may predispose them to priapism (e.g. Sickle cell anemia) as per Investigatorâ??s discretion
11) Patient with history of hereditary degenerative retinal disorders (e.g., retinitis pigmentosa) or ischemic optic neuropathy including non-arteritic anterior ischemic optic neuropathy (NAION)
12) Use of any 5-alpha reductase inhibitor, androgens, anti-androgens, any drugs with androgenic or anti-androgenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, metronidazole, progestational agents), anabolic steroids, LHRH agonists/antagonists or other drugs which affect prostate volume, within past 3 months of the screening visit
13) Patient on nitrates or beta-agonists within 2 weeks of screening or who are planning to take during the study
14) Patient using strong inhibitors of CYP3A4 (e.g. ketoconazole, ritonavir, itraconazole), moderate inhibitors of CYP3A4 (e.g. erythromycin), strong or moderate inhibitors of CYP2D6 (e.g. paroxetine, terbinafine), CYP3A4 inducers (e.g. rifampin), GC stimulator (e.g. riociguat) at screening
15) Patients with glycosylated hemoglobin (HbA1c) >= 7.5 % at screening
16) Patient with moderate to severe renal impairment (Creatinine clearance < 50 mL/min) and hepatic impairment (AST and ALT Ë? 3 x ULN)
17) Patient with history of HIV and / or Hepatitis B and/ or Hepatitis C
18) Patient with history of bleeding disorders or
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method