Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

  • STATUS
    Recruiting
  • End date
    Jun 15, 2023
  • participants needed
    654
  • sponsor
    Dongkook Pharmaceutical Co., Ltd.
Updated on 15 December 2021
transrectal ultrasound
benign prostatic hyperplasia
hyperplasia

Summary

This is a multi-center, randomized, double-blinded, double-dummy, parallel group, 48-week study to evaluated the efficacy and safety of DKF-313 (dutasteride and tadalafil) in patients with benign prostatic hyperplasia.

Description

This study is conducted to access whether DKF-313 once daily for 48 weeks is superior to dutasteride 0.5 mg once daily and tadalafil 5 mg once daily each in improving BPH-LUTS as measured by changes in IPSS total scores.

Details
Condition Benign Prostatic Hyperplasia
Treatment Tadalafil, dutasteride, DKF-313, Tadalafil Placebo, DKF-313 placebo, Dutasteride placebo
Clinical Study IdentifierNCT04947631
SponsorDongkook Pharmaceutical Co., Ltd.
Last Modified on15 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male aged 45 to 80 years
BPH diagnosis
Voluntarily signed the informed consent form
Willing to participate in the study
Total IPSS 13 or greater at baseline
Prostate volume 30 cc or greater by TRUS at baseline
Qmax 4 to 15 mL/s and minimum voided volume 125 mL or greater at baseline

Exclusion Criteria

Serum PSA 4 ng/mL or greater with a positive biopsy result
Malignant urogenital tumors including prostate cancer, bladder cancer, etc
Previous prostatic surgery including TURP, balloon dilatation, thermotherapy and stent replacement or other invasive procedures to treat prostate
Prostate biopsy within 4 weeks of screening
Use of alpha-blockers, alpha-agonists, phosphodiesterase type 5 (PDE5) inhibitors, antidiuretics, anticholinergics, cholinergics, antispasmodics, nitrates or herbal preparations affecting prostate within 4 weeks of screening, or 5-alpha reductase inhibitors (5-ARIs) within 24 weeks of screening
Acute urinary retention within 12 weeks of screening
Any causes other than BPH resulting in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, acute or chronic urinary tract infections)
Bladder postvoid residual 200 mL or greater
Anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or conditions that might predispose to priapism (such as sickle cell anemia, multiple myeloma, or leukemia)
Cardiovascular diseases such as myocardial infarction within 12 weeks of screening, unstable angina or angina during sexual intercourse, heart failure (NYHA Class 2 or higher) within 24 weeks of screening, uncontrolled arrhythmias, hypotension (<90/50 mmHg) or uncontrolled hypertension (>170/100 mmHg), or stroke within 24 weeks of screening
Left ventricular outflow obstruction (e.g. aortic stenosis and idiopathic hypertrophic subaortic stenosis)
Inherited disorders including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Inherited retinal degeneration including retinitis pigmentosa
Vision loss in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION)
Hypersensitivity to ingredients of investigational products
Alcohol or drug abuse or treating psychiatric disorders
Severe hepatic impairment (ALT or AST > 3xULN)
Renal impairment with severe heart failure (serum creatinine > 2xULN)
Uncontrolled diabetes (HbA1c 9% or greater)
Other investigational products or procedures within 12 weeks of screening
Plans to have a child or unwilling to comply with using medically accepted contraception methods (such as surgical sterilization and condom) during the treatment period
Not eligible due to other reasons at the investigator's discretion
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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