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Role of Dutasteride in Treatment of Chronic Prostatitis

Primary Purpose

Dutasteride, Category IIIB Chronic Prostatitis

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Dutasteride 0.5 mg
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dutasteride

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • patients aged between 40 and 70 years old, diagnosed with chronic prostatitis based on the presence of pelvic pain for ≥3 months of the preceding 6 months

Exclusion Criteria:

Patients with bacterial prostatitis

  • documented site of infection along the urinary tract,
  • urinary bladder tumors
  • prostate cancer
  • previous history of pelvic radiation or chemotherapy were excluded from our study.

Sites / Locations

  • Urology department - ain shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dutasteride

Placebo

Arm Description

Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo.

same form and color of Dutasteride tablet was given at the same regimen to act as a placebo

Outcomes

Primary Outcome Measures

NIH chronic prostatitis symptom index in study population
scoring system aims to evaluate chronic prostatitis and severity of symptoms
NIH chronic prostatitis symptom index in study population
scoring system aims to evaluate chronic prostatitis and severity of symptoms

Secondary Outcome Measures

change in libido in study population
according to sexual desire inventory -2
Gastritis in study population
side effect of medication (if present or not)
Dizziness in study population
side effect of medication (if present or not)

Full Information

First Posted
February 5, 2021
Last Updated
February 11, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04756206
Brief Title
Role of Dutasteride in Treatment of Chronic Prostatitis
Official Title
Role of Dutasteride in Treatment of Category IIIB Chronic Prostatitis (A Placebo-Controlled Study)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
this placebo controlled study aims to evaluate the efficacy of Dutasteride in the management of Chronic prostatitis type 3.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dutasteride, Category IIIB Chronic Prostatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dutasteride
Arm Type
Active Comparator
Arm Description
Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
same form and color of Dutasteride tablet was given at the same regimen to act as a placebo
Intervention Type
Drug
Intervention Name(s)
Dutasteride 0.5 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
NIH chronic prostatitis symptom index in study population
Description
scoring system aims to evaluate chronic prostatitis and severity of symptoms
Time Frame
assessment was made before treatment
Title
NIH chronic prostatitis symptom index in study population
Description
scoring system aims to evaluate chronic prostatitis and severity of symptoms
Time Frame
assessment was made at 3 months after intervention
Secondary Outcome Measure Information:
Title
change in libido in study population
Description
according to sexual desire inventory -2
Time Frame
3 months after medication
Title
Gastritis in study population
Description
side effect of medication (if present or not)
Time Frame
3 months after medication
Title
Dizziness in study population
Description
side effect of medication (if present or not)
Time Frame
3 months after medication

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Chronic prostatitis is a disease that affects men only.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients aged between 40 and 70 years old, diagnosed with chronic prostatitis based on the presence of pelvic pain for ≥3 months of the preceding 6 months Exclusion Criteria: Patients with bacterial prostatitis documented site of infection along the urinary tract, urinary bladder tumors prostate cancer previous history of pelvic radiation or chemotherapy were excluded from our study.
Facility Information:
Facility Name
Urology department - ain shams university
City
Cairo
ZIP/Postal Code
11361
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Dutasteride in Treatment of Chronic Prostatitis

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