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.

Phase 4

Not yet recruiting

• Conditions: Benign prostatic hyperplasia without lower urinary tract symptoms,

• Registration Number: CTRI/2022/06/043152
• Lead Sponsor: Sun Pharma Laboratory Limited SPLL

Brief Summary

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|This will be a prospective, multi-center, single-arm, Phase IV, open-label study. The study will be conducted at approximately 15 to 25 centers in India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and EC approval.

Screening period

After obtaining the informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessment (Appendix I). The total duration of study will be of 17 weeks, which includes 5 weeks (maximum) of screening period [inclusive of 28 days of washout period]. Patients using drugs to treat BPH or medications that could act on bladder function (alpha blockers, anticholinergics etc.,) or PDE5Is will undergo a 4-week medication free wash out period before the study treatment. During washout period if patient is not able to continue without medications then he will be considered as screened failure. During washout period patient can continue medications that are not prohibited for the study for acceptable co-morbid conditions.

Treatment period

Treatment period will be of 12 weeks. Eligible patients will be given FDC of Tamsulosin HCI PR and Tadalafil (0.4 mg + 5 mg) capsules once daily during study duration.

The study consists of following visits:

Visit 1 (Day -35 to -1): Screening and 28 days washout period

Visit 2 (Day 1): Enrolment & Baseline visit

Visit 3 (Day 28 ± 3 Days) (Week 4): Treatment visit

Visit 4 (Day 56 ± 3 Days) (Week 8): Treatment visit

Visit 5 (Day 84 ± 3 Days) (Week 12): End of Study visit

Patients who are terminating early from the study will be completing Visit 5 assessments. Visit 5 will be considered as early treatment (ET)/end of study visit (EOS). The safety and efficacy will be assessed during the study period as mentioned in Schedule of Assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-15
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 patient’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 Investigator’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 ˃ 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 significant active peptic ulceration 19) Patient with history of cancer or undergoing cancer chemo or radiotherapy 20) Patient having hypersensitivity or any other contraindication to any of the Investigational products including its components; or history of hypersensitivity reaction to sulfa drugs 21) Patient involved in profession like driving, operating heavy machinery or performing hazardous work 22) Patient who have participated in another Investigational study within the 3 months prior to enrolment in this study 23) Patient with known alcohol or other substance abuse within last one year as per DSM-5 criteria 24) Investigator, study personnel, sponsor representatives and their first degree relatives.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety:	12 Weeks
1. Proportion of participants with treatment-emergent adverse events (TEAEs)	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Efficacy	1. Change in Total International Prostate Symptom Score (IPSS) from baseline [Time frame: 4, 8 and 12 weeks]

Trial Locations

Locations (16)

Sparsh Super Specialty Hospital.; 🇮🇳 Bangalore, KARNATAKA, India

Ace hospital and research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Advanced urology centre, Post graduate Institute of medical education and research; 🇮🇳 Chandigarh, CHANDIGARH, India

Anand Multispecialty Hospital; 🇮🇳 Vadodara, GUJARAT, India

Dr. M K Shah Medical college & Research Centre, Smt. SMS Multispecialty Hospital,; 🇮🇳 Ahmadabad, GUJARAT, India

Gandhi Hospital; 🇮🇳 Hyderabad, TELANGANA, India

GSVM Medical College; 🇮🇳 Dehat, UTTAR PRADESH, India

Indus Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Institute of Post Graduate Medical Education & Research; 🇮🇳 Kolkata, WEST BENGAL, India

Jaipur National University, Institute for Medical Sciences and Research Centre; 🇮🇳 Jaipur, RAJASTHAN, India

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Sparsh Super Specialty Hospital.

🇮🇳Bangalore, KARNATAKA, India

Dr Avinash TS

Principal investigator

09606197707

Sparshclinical@gmail.com