Role of Dutasteride in Treatment of Chronic Prostatitis

NCT04756206 | Completed Phase 2 DMC

• 1 other identifier: R21/2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dutasteride; Category IIIB Chronic Prostatitis

Outcome Measures

Primary Outcomes (2)

• NIH chronic prostatitis symptom index in study population

  scoring system aims to evaluate chronic prostatitis and severity of symptoms

  assessment was made before treatment

• NIH chronic prostatitis symptom index in study population

  scoring system aims to evaluate chronic prostatitis and severity of symptoms

  assessment was made at 3 months after intervention

Secondary Outcomes (3)

• change in libido in study population

  3 months after medication

• Gastritis in study population

  3 months after medication

• Dizziness in study population

  3 months after medication

Study Arms (2)

Dutasteride

ACTIVE COMPARATOR

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

Drug: Dutasteride 0.5 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Dutasteride 0.5 mg DRUG

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.

Dutasteride

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: Chronic prostatitis is a disease that affects men only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Urology department - ain shams university

Cairo, 11361, Egypt

Location

Related Publications (1)

• Higazy A, Shorbagy AA, Shabayek M, Radwan A, Halim GN, Osman D, Osman T. Short course of dutasteride in treatment of a refractory category IIIB chronic prostatitis (A placebo-controlled study). Prostate Int. 2022 Dec;10(4):213-217. doi: 10.1016/j.prnil.2022.06.002. Epub 2022 Jun 20.

  PMID: 36570649 DERIVED

MeSH Terms

Interventions

Dutasteride

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 16, 2021
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)