A Phase 2/3 interventional study of Dutasteride 0.5 mg and Placebo in Dutasteride and Category IIIB Chronic Prostatitis, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to male participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-16.
Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment
this placebo controlled study aims to evaluate the efficacy of Dutasteride in the management of Chronic prostatitis type 3.
Nonbacterial prostatitis refers to a condition that affects patients who present with symptoms of prostatitis without a positive culture for urine or expressed prostate secretions (EPS). With time our understanding of prostatitis was evolved to include a different clinical phenotype with a variety of voiding presentation and symptomatology rather than just inflammation and infection. The two main clinical presentations of prostatitis include pelvic pain and LUTS.
The National Institutes of Health and the National Institute of Diabetes and Digestive and Kidney Diseases (NIH-NIDDK) proposed the first classification of prostatitis into 4 categories in 1995 that was later published in 1998. Bacterial prostatitis represented category I and III while nonbacterial prostatitis including chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) was categorized as category III that was further subdivided into class IIIa (inflammatory CPPS) and b (non-inflammatory CPPS). Category IV encompasses asymptomatic inflammatory prostatitis.
Shoskes et al, mentioned that inflammation and the upregulation of cytokine expression and release in the prostate secondary to an inflammatory process led to the presenting symptoms in such a condition. The recently introduced UPOINT phenotype categorization of CP/CPPS (Urinary, Psychosocial, Organ-specific, Infection, Neurological/Systemic, Tenderness of the skeletal muscles). This categorization shows up to 60% of men have at least prostate organ associated symptoms.
The prostate lies under the hormonal control of dihydrotestosterone (DHT); thus 5 alpha-reductase inhibitors (5ARIs) might be beneficial in the treatment of prostatitis. Dutasteride is a 5α-reductase inhibitor, and hence is a type of anti-androgen. It works by decreasing the production of (DHT) in certain parts of the body like the prostate gland. It inhibits all three forms of 5α-reductase and can decrease DHT levels in the blood by up to 98%.
5ARIs have been previously evaluated on a narrow scale in the management of prostatitis with promising results of safety and efficacy.
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients with bacterial prostatitis
Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo.
Drug: Dutasteride 0.5 mg
same form and color of Dutasteride tablet was given at the same regimen to act as a placebo
Drug: Placebo
patients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention.
patients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention.
NIH chronic prostatitis symptom index in study population
scoring system aims to evaluate chronic prostatitis and severity of symptoms
Time frame: assessment was made before treatment
NIH chronic prostatitis symptom index in study population
scoring system aims to evaluate chronic prostatitis and severity of symptoms
Time frame: assessment was made at 3 months after intervention
change in libido in study population
according to sexual desire inventory -2
Time frame: 3 months after medication
Gastritis in study population
side effect of medication (if present or not)
Time frame: 3 months after medication
Dizziness in study population
side effect of medication (if present or not)
Time frame: 3 months after medication
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Jan 2020, 12 months.
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dutasteride