The efficacy and safety of the combination of terazosin and tadalafil in men with lower urinary tract symptoms due to benign prostatic hyperplasia: a randomized, active controlled, multi-center clinical trial

Not Applicable

• Conditions: Diseases of The genitoruinary system

• Registration Number: KCT0004492
• Lead Sponsor: Kangdong Sacred Heart Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 124

Inclusion Criteria

1) Men over 45 years old
2) Patients diagnosed with lower urinary tract symptoms due to benign prostatic hyperplasia
3) Patients whose maximum urinary flow rate Qmax is from 5 to 15 mL/sec at Visit 2
4) Patients who has minimum voided volume> 125mL at Visit 2
5) Patients whose PSA(Prostate specific antigen) = 4.0ng/mL factor at Visit 1(except 4.0ng/mL is negative if biopsy results)
6) Patients whose prostate hyperplasia has been confirmed by rectal examination at Visit 1
7) Patients who has a fixed relationship with one female partner who can maintain a relationship during the examination
8) Patients who can have sexual intercourse attempts at least 4 times during a four-week free run-in period, once per day on different days.
9) After four weeks of free run-in, both of the following criteria are met:
   - Total IPSS score = 13 points
   - IIEF-EF domain = 24 points, and items 3 and 4 of IIEF are 3 points
10) Patients who understand the clinical trial's process and signed the consent voluntarily

Exclusion Criteria

1) Patients have other conditions that can cause lower urinary tract symptoms other than prostatic hyperplasia: prostate cancer, lower urinary tract cancer, including bladder cancer, neurogenic bladder, lower urinary tract infection, urethral stricture, bladder stenosis neck contracture, prostatitis, etc.
2) Patients who have a PVR (post void residual volume) measured at Visit 2 300mL or more.
3) Patients had or have suspected orthostatic hypotension, dizziness, dizziness, loss of consciousness, fainting.
4) Patients who have undergone surgery on the Urinary tract, such as the prostate, urethra, or bladder, or invasive to the prostate for the treatment of other prostates, or who have been planned during clinical trials.
5) Patients who have an anatomic malformation of the penis or have a history of penile anorexia due to medication.
6) Patients who have had pelvic surgery within 6 months before screening.
7) Patients with hypersensitivity to the components of the study drug or sulfa drug.
8) Patients who had acute urinary retention within 4 weeks prior to screening.
9) Patients currently suspected or diagnosed with lower urinary tract stones or bladder stones.
10) Patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
11) Patients with uncontrolled diabetics.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total IPSS change after 12 weeks compared to Baseline(Visit 2)

Secondary Outcome Measures

Name	Time	Method
Total IPSS change after 4 weeks compared to Baseline(Visit 2);Changes in IPSS sub score after 4 and 12 weeks from baseline: Storage, voiding;Changes in IPSS QoL after 4 and 12 weeks compared to Baseline(Visit2);Changes in Qmax after 4 and 12 weeks from baseline(Visit 2);Changes in PVR after 4 and 12 weeks compared to Baseline(Visit 2);PGIC, CGIC (Patient and Clinician Global Impression of Change) at end point;Total change in International Index of Erectile Function sum of questions (IIEF) after 4 and 12 weeks from Visit 2;Changes in IIEF-IS (Intercourse satisfaction, 6 ~ 8), OS (Overall satisfaction, 13 ~ 14), OF (Orgasmic function, 9, 10) domain after 4 and 12 weeks;IIEF-EF domain (Erectile function, 1 ~ 5 & 15) 4 weeks after baseline (Visit 2) Change;Changes in scores 3 and 4 of the IIEF after 12 weeks compared to Visit 2;Response rate and improvement rate of scores 3 and 4 of IIEF after 12 weeks compared to Visit 2