Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia
A Multi-center, Randomized, Double-blinded, Double-dummy, Parallel Group, 48-week, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia
1 other identifier
interventional
667
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2021
CompletedFirst Posted
Study publicly available on registry
July 1, 2021
CompletedStudy Start
First participant enrolled
July 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2023
CompletedSeptember 21, 2023
September 1, 2023
1.9 years
May 19, 2021
September 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Total International Prostate Symptom Score (IPSS) from baseline to Week 48
Weeks 0 and 48
Secondary Outcomes (8)
Change in Total International Prostate Symptom Score (IPSS) from baseline to Weeks 4, 12, 24 and 36
Weeks 0, 4, 12, 24 and 36
Change in Total International Prostate Symptom Score (IPSS) voiding (obstructive) subscores from baseline to Weeks 4, 12, 24, 36 and 48
Weeks 0, 4, 12, 24, 36 and 48
Change in Total International Prostate Symptom Score (IPSS) storage (irritative) subscores from baseline to Weeks 4, 12, 24, 36 and 48
Weeks 0, 4, 12, 24, 36 and 48
Change in Total International Prostate Symptom Score (IPSS) Quality of Life (QoL) index from baseline to Weeks 4, 12, 24, 36 and 48
Weeks 0, 4, 12, 24, 36 and 48
Change in Qmax from baseline to Weeks 24 and 48
Weeks 0, 24 and 48
- +3 more secondary outcomes
Other Outcomes (2)
Change in International Index of Erectile Function (IIEF) - Erectile Function (EF) domain scores from baseline to Weeks 4, 12, 24, 36 and 48
Weeks 0, 4, 12, 24, 36 and 48
Change in Sexual Encounter Profile (SEP) Q2 and Q3 from baseline to Weeks 4, 12, 24, 36 and 48
Weeks 0, 4, 12, 24, 36 and 48
Study Arms (3)
DKF-313
EXPERIMENTALDutasteride 0.5mg + Tadalafil 5mg
Dutasteride
ACTIVE COMPARATORDutasteride 0.5mg
Tadalafil
ACTIVE COMPARATORTadalafil 5mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ewha Womans University mokdong Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Choung-Soo Kim, M.D.,Ph.D
Ewha Womans University Mokdong Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2021
First Posted
July 1, 2021
Study Start
July 27, 2021
Primary Completion
June 12, 2023
Study Completion
June 12, 2023
Last Updated
September 21, 2023
Record last verified: 2023-09